Clinical Neurobiology of Serotonin and Addiction
NCT00732901, Phase 2, Phase 3, Completed, Virginia Commonwealth University; results first posted 2017-03-30
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinical Neurobiology of Serotonin and Addiction | ClinicalTrials.gov |
| NCT number | NCT00732901 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 160 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Virginia Commonwealth University | ClinicalTrials.gov |
| Conditions | Cocaine Dependence | ClinicalTrials.gov |
| Interventions | Escitalopram, Placebo | ClinicalTrials.gov |
| First posted | 2008-08-12 | ClinicalTrials.gov |
| Last updated | 2019-03-08 | ClinicalTrials.gov |
| Results first posted | 2017-03-30 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Immediate Memory Task | after acute dose and after chronic administration | The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses. | ClinicalTrials.gov |
| Secondary | Attentional Bias as Measured by the Cocaine Stroop Task. | 5 weeks of treatment | Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias. | ClinicalTrials.gov |
| Secondary | Cocaine Positive Urines | 5 weeks of treatment | Number of urine drug screens positive for cocaine metabolite benzoylecgonine. | ClinicalTrials.gov |
Outcomes 3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Immediate Memory Task | after acute dose and after chronic administration | Numerical data values are not accessible because PI transferred institutions. See references. | ClinicalTrials.gov | ||
| SECONDARY | Attentional Bias as Measured by the Cocaine Stroop Task. | 5 weeks of treatment | milliseconds | MEAN | ClinicalTrials.gov | |
| SECONDARY | Cocaine Positive Urines | 5 weeks of treatment | Positive urine drug screens | NUMBER | ClinicalTrials.gov |
Results by group 14
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 Measured by the Cocaine Stroop Task. | A (Escitalopram) | Baseline | 90.2 | Standard Deviation 107.8 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | B (Placebo) | Baseline | 45.9 | Standard Deviation 109.2 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | A (Escitalopram) | Acute | -8.6 | Standard Deviation 21.6 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | B (Placebo) | Acute | 37.4 | Standard Deviation 93.8 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | A (Escitalopram) | Chronic Day 1 | 56.4 | Standard Deviation 58.7 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | B (Placebo) | Chronic Day 1 | 35.4 | Standard Deviation 77.9 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | A (Escitalopram) | Chronic Day 2 | 45.0 | Standard Deviation 68.6 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | B (Placebo) | Chronic Day 2 | 15.4 | Standard Deviation 64.5 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | A (Escitalopram) | Chronic Day 3 | 23.4 | Standard Deviation 33.0 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | B (Placebo) | Chronic Day 3 | -11.3 | Standard Deviation 68.0 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | A (Escitalopram) | Chronic Day 4 | 63.6 | Standard Deviation 82.5 | milliseconds | ClinicalTrials.gov |
| Attentional Bias as Measured by the Cocaine Stroop Task. | B (Placebo) | Chronic Day 4 | 4.4 | Standard Deviation 76.2 | milliseconds | ClinicalTrials.gov |
| Cocaine Positive Urines | A (Escitalopram) | 9 | Positive urine drug screens | ClinicalTrials.gov | ||
| Cocaine Positive Urines | B (Placebo) | 8 | Positive urine drug screens | 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 | A (Escitalopram) | 11 | ClinicalTrials.gov | |
| Overall Study | STARTED | B (Placebo) | 12 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | A (Escitalopram) | 11 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | B (Placebo) | 12 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | A (Escitalopram) | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | B (Placebo) | 0 | ClinicalTrials.gov |
Adverse events 0
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 |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | A (Escitalopram) | ClinicalTrials.gov | ||
| Total, all-cause mortality | B (Placebo) | ClinicalTrials.gov | ||
| Total, other adverse events | A (Escitalopram) | 0 | 11 | ClinicalTrials.gov |
| Total, other adverse events | B (Placebo) | 0 | 12 | ClinicalTrials.gov |
| Total, serious adverse events | A (Escitalopram) | 0 | 11 | ClinicalTrials.gov |
| Total, serious adverse events | B (Placebo) | 0 | 12 | ClinicalTrials.gov |
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 1
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 |
|---|---|---|---|---|---|---|
| P20DA024157 | Translational Center on Serotonin and Stimulant Addiction | CUNNINGHAM, KATHRYN A. | UNIVERSITY OF TEXAS MED BR GALVESTON | NATIONAL INSTITUTE ON DRUG ABUSE | 2007 to 2012 | NIH RePORTER |
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A (Escitalopram) vs B (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 |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Immediate and Delayed Memory Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | 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)