Psychopharmacology for Cocaine Dependence - Buspirone
NCT01267292, Phase 2, Completed, The University of Texas Health Science Center, Houston; results first posted 2017-05-04
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Psychopharmacology for Cocaine Dependence - Buspirone | ClinicalTrials.gov |
| NCT number | NCT01267292 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 50 participants, actual | ClinicalTrials.gov |
| Lead sponsor | The University of Texas Health Science Center, Houston | ClinicalTrials.gov |
| Conditions | Cocaine Dependence | ClinicalTrials.gov |
| Interventions | Buspirone, Placebo for Buspirone, Methylphenidate, Placebo for Methylphenidate | ClinicalTrials.gov |
| First posted | 2010-12-28 | ClinicalTrials.gov |
| Last updated | 2017-05-04 | ClinicalTrials.gov |
| Results first posted | 2017-05-04 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Attentional Bias as Assessed by Score on the Stroop Task | 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3 | The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm. The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the screen, by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words. | ClinicalTrials.gov |
| Primary | Risky Decision Making as Assessed by Score on the Risky Decision Making Task | 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3 | The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm. The risky decision making task provides subjects with three choice options on each of 100 repeated trials. Options are low, moderate, and high risk, based on variance and probability in gain/loss amounts. The low risk option is more adaptive over many trials. The outcome measure is a risk index (ranging from 0.33 to 100) that factors in tolerance for variability and amount of gains and losses across the three options. 100 is highest risk. 0.33 is lowest risk. | ClinicalTrials.gov |
| Secondary | Subjective Effects as Assessed by the Addiction Research Center Inventory (ARCI) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | The ARCI short form will be used. It is a 49-item true / false questionnaire that has been empirically-derived to assess five different factors, including euphoria, sedation, and dysphoria. The PCAG scale has proven to be a sensitive measure of subjective effects in many studies administering stimulant drugs. | ClinicalTrials.gov |
| Secondary | Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm. The POMS is a self-rating measure of current mood, consisting of six subscales demonstrated to be sensitive to a range of acute drug effects, including amphetamine, cocaine, and caffeine. The six subscales are: depression, vigor, confusion, tension, anxiety, and fatigue. A 37-item short form of the POMS was used, which correlates highly with the full scale. The vigor subscale is reported, and the vigor subscale score ranges from 0 to 28, with 28 representing the highest score for that mood state. The higher the value, the worse the outcome. | ClinicalTrials.gov |
| Secondary | Subjective Effects as Assessed by Score on the "Feel High" Subscale of the Drug Effects Questionnaire (DEQ) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm. The DEQ is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug," "Feel High," "Like Drug," and "Want More." The "Feel High" subscale is reported, and this subscale is scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. | ClinicalTrials.gov |
| Secondary | Subjective Effects as Assessed by the "Elated" Subscale of the Visual Analogue Scale (VAS) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm. The VAS presents 100-mm horizontal lines labeled with an adjective: "stimulated," "high," "anxious," "elated," "hungry," and "nauseated." The "elated" subscale is reported, and this sub scale is anchored by "not at all" (0) on the left and "extremely" (100) on the right, with a score range of 0-100. The higher the score, the worse the outcome. | ClinicalTrials.gov |
| Secondary | Heart Rate | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm. Heart rate is the measure of heart beats per minute. | ClinicalTrials.gov |
| Secondary | Systolic Blood Pressure | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm. Systolic blood pressure is the amount of pressure in the arteries during contraction of the heart muscle. | ClinicalTrials.gov |
| Secondary | Diastolic Blood Pressure | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm. Diastolic blood pressure is the blood pressure when the heart muscle is between beats. | ClinicalTrials.gov |
| Secondary | Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT) | baseline | Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A "hit" response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a "false alarm." The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination). | ClinicalTrials.gov |
| Secondary | Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT) | Thursday of week 1 | Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A "hit" response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a "false alarm." The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination). | ClinicalTrials.gov |
| Secondary | Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT) | Monday of week 4 | Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A "hit" response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a "false alarm." The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination). | ClinicalTrials.gov |
| Secondary | Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task | baseline | The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials. | ClinicalTrials.gov |
| Secondary | Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task | Thursday of week 1 | The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials. | ClinicalTrials.gov |
| Secondary | Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task | Monday of week 4 | The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials. | ClinicalTrials.gov |
Outcomes 15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Attentional Bias as Assessed by Score on the Stroop Task | 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3 | milliseconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | Risky Decision Making as Assessed by Score on the Risky Decision Making Task | 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3 | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Subjective Effects as Assessed by the Addiction Research Center Inventory (ARCI) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | ARCI data were not collected. | ClinicalTrials.gov | ||
| SECONDARY | Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Subjective Effects as Assessed by Score on the Feel High Subscale of the Drug Effects Questionnaire (DEQ) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Subjective Effects as Assessed by the Elated Subscale of the Visual Analogue Scale (VAS) | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Heart Rate | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | beats per minute | MEAN | ClinicalTrials.gov | |
| SECONDARY | Systolic Blood Pressure | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | mmHg | MEAN | ClinicalTrials.gov | |
| SECONDARY | Diastolic Blood Pressure | 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 | mmHg | MEAN | ClinicalTrials.gov | |
| SECONDARY | Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT) | baseline | a-prime | MEAN | ClinicalTrials.gov | |
| SECONDARY | Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT) | Thursday of week 1 | a-prime | MEAN | ClinicalTrials.gov | |
| SECONDARY | Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT) | Monday of week 4 | a-prime | MEAN | ClinicalTrials.gov | |
| SECONDARY | Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task | baseline | number of perseverative errors | MEAN | ClinicalTrials.gov | |
| SECONDARY | Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task | Thursday of week 1 | number of perseverative errors | MEAN | ClinicalTrials.gov | |
| SECONDARY | Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task | Monday of week 4 | number of perseverative errors | MEAN | ClinicalTrials.gov |
Results by group 76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Attentional Bias as Assessed by Score on the Stroop Task | Buspirone Plus Methylphenidate | 15 mg methylphenidate | -13.90333 | Standard Deviation 62.76434 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Assessed by Score on the Stroop Task | Placebo for Buspirone Plus Methylphenidate | 15 mg methylphenidate | 27.118 | Standard Deviation 58.84988 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Assessed by Score on the Stroop Task | Buspirone Plus Methylphenidate | 30 mg methylphenidate | -9.361269 | Standard Deviation 30.66139 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Assessed by Score on the Stroop Task | Placebo for Buspirone Plus Methylphenidate | 30 mg methylphenidate | 15.35407 | Standard Deviation 66.51272 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Assessed by Score on the Stroop Task | Buspirone Plus Methylphenidate | 60 mg methylphenidate | 15.59167 | Standard Deviation 142.0095 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Assessed by Score on the Stroop Task | Placebo for Buspirone Plus Methylphenidate | 60 mg methylphenidate | 23.28063 | Standard Deviation 42.25839 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Assessed by Score on the Stroop Task | Buspirone Plus Methylphenidate | 0 mg methylphenidate | 4.688844 | Standard Deviation 30.59728 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Assessed by Score on the Stroop Task | Placebo for Buspirone Plus Methylphenidate | 0 mg methylphenidate | 41.22625 | Standard Deviation 74.82985 | milliseconds | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Buspirone Plus Methylphenidate | 15mg Methylphenidate | 9.126667 | Standard Deviation 5.094545 | units on a scale | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Placebo for Buspirone Plus Methylphenidate | 15mg Methylphenidate | 10.07396 | Standard Deviation 5.44448 | units on a scale | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Buspirone Plus Methylphenidate | 30mg Methylphenidate | 10.77167 | Standard Deviation 6.58645 | units on a scale | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Placebo for Buspirone Plus Methylphenidate | 30mg Methylphenidate | 9.699333 | Standard Deviation 6.334753 | units on a scale | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Buspirone Plus Methylphenidate | 60mg Methylphenidate | 8.946263 | Standard Deviation 6.947867 | units on a scale | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Placebo for Buspirone Plus Methylphenidate | 60mg Methylphenidate | 7.889825 | Standard Deviation 5.277534 | units on a scale | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Buspirone Plus Methylphenidate | 0mg Methylphenidate | 11.415 | Standard Deviation 6.147164 | units on a scale | ClinicalTrials.gov |
| Risky Decision Making as Assessed by Score on the Risky Decision Making Task | Placebo for Buspirone Plus Methylphenidate | 0mg Methylphenidate | 8.715333 | Standard Deviation 6.34345 | units on a scale | ClinicalTrials.gov |
| Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) | Buspirone Plus Methylphenidate | 15mg Methylphenidate | 4.609626 | Standard Deviation 5.775599 | units on a scale | ClinicalTrials.gov |
| Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) | Placebo for Buspirone Plus Methylphenidate | 15mg Methylphenidate | 3.770115 | Standard Deviation 4.558423 | units on a scale | ClinicalTrials.gov |
| Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) | Buspirone Plus Methylphenidate | 30mg Methylphenidate | 9.924324 | Standard Deviation 6.630357 | units on a scale | ClinicalTrials.gov |
| Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS) | Placebo for Buspirone Plus Methylphenidate | 30mg Methylphenidate | 6.268571 | Standard Deviation 5.721696 | units on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Buspirone Plus Methylphenidate | 24 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo for Buspirone Plus Methylphenidate | 26 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Buspirone Plus Methylphenidate | 20 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo for Buspirone Plus Methylphenidate | 20 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Buspirone Plus Methylphenidate | 4 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo for Buspirone Plus Methylphenidate | 6 | ClinicalTrials.gov |
Adverse events 4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Elevated Blood pressure (transient) | Cardiac disorders | Buspirone | 0 | 20 | 0 | ClinicalTrials.gov |
| other | Elevated Blood pressure (transient) | Cardiac disorders | Placebo | 1 | 20 | 1 | ClinicalTrials.gov |
| other | Upset stomach/nausea | Gastrointestinal disorders | Buspirone | 0 | 20 | 0 | ClinicalTrials.gov |
| other | Upset stomach/nausea | Gastrointestinal disorders | Placebo | 1 | 20 | 1 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Buspirone | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Buspirone | 0 | 20 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 1 | 20 | ClinicalTrials.gov |
| Total, serious adverse events | Buspirone | 0 | 20 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 0 | 20 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buspirone vs Placebo: serious adverse events | Trial comparisons |
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Immediate and Delayed Memory Task | Secondary outcome | ConductCognition |
| Probabilistic Reversal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)