Trial · NCT01511640
Behavioral Effects of Pregabalin and Cannabis
NCT01511640, Early phase 1, Completed, Joshua A. Lile, Ph.D.; results first posted 2021-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Behavioral Effects of Pregabalin and Cannabis. Trials, record NCT01511640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01511640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Behavioral Effects of Pregabalin and Cannabis
- NCT number
- NCT01511640
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Joshua A. Lile, Ph.D.
- Conditions
- Cannabis-use Disorders
- Interventions
- Pregabalin, Placebo
- First posted
- 2012-01-18
- Last updated
- 2021-09-10
- Results first posted
- 2021-09-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level. | The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level. | Cannabis puffs | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 300 mg/Day Pregabalin | 0% placebo Cannabis | 2.00 | Standard Error 0.92 | Cannabis puffs |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 0 mg/Day Pregabalin (Placebo 1) | 0% placebo Cannabis | 2.67 | Standard Error 0.92 | Cannabis puffs |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 450 mg/Day Pregabalin | 0% placebo Cannabis | 3.60 | Standard Error 1.15 | Cannabis puffs |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 0 mg/Day Pregabalin (Placebo 2) | 0% placebo Cannabis | 4.00 | Standard Error 0.88 | Cannabis puffs |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 300 mg/Day Pregabalin | 5.9% active Cannabis | 5.75 | Standard Error 0.95 | Cannabis puffs |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 0 mg/Day Pregabalin (Placebo 1) | 5.9% active Cannabis | 5.67 | Standard Error 0.77 | Cannabis puffs |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 450 mg/Day Pregabalin | 5.9% active Cannabis | 5.40 | Standard Error 0.85 | Cannabis puffs |
| Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions | 0 mg/Day Pregabalin (Placebo 2) | 5.9% active Cannabis | 4.80 | Standard Error 0.76 | Cannabis puffs |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (11-15 Days) | STARTED | 300 mg/Day Pregabalin, Then Placebo | 7 | |
| First Intervention (11-15 Days) | STARTED | Placebo, Then 300 mg/Day Pregabalin | 8 | |
| First Intervention (11-15 Days) | STARTED | 450 mg/Day Pregabalin, Then Placebo | 7 | |
| First Intervention (11-15 Days) | STARTED | Placebo, Then 450 mg/Day Pregabalin | 8 | |
| First Intervention (11-15 Days) | COMPLETED | 300 mg/Day Pregabalin, Then Placebo | 5 | |
| First Intervention (11-15 Days) | COMPLETED | Placebo, Then 300 mg/Day Pregabalin | 8 | |
| First Intervention (11-15 Days) | COMPLETED | 450 mg/Day Pregabalin, Then Placebo | 7 | |
| First Intervention (11-15 Days) | COMPLETED | Placebo, Then 450 mg/Day Pregabalin | 7 | |
| First Intervention (11-15 Days) | NOT COMPLETED | 300 mg/Day Pregabalin, Then Placebo | 2 | |
| First Intervention (11-15 Days) | NOT COMPLETED | Placebo, Then 300 mg/Day Pregabalin | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events8
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 |
|---|---|---|---|---|---|---|
| other | nausea/vomiting | Gastrointestinal disorders | 300 mg/Day Pregabalin | 0 | 12 | 0 |
| other | nausea/vomiting | Gastrointestinal disorders | 0 mg/Day Pregabalin (Placebo 1) | 1 | 13 | 1 |
| other | nausea/vomiting | Gastrointestinal disorders | 450 mg/Day PregabalinPregabalin | 13 | ||
| other | nausea/vomiting | Gastrointestinal disorders | 0 mg/Day Pregabalin (Placebo 2) | 14 | ||
| other | chest pain | Musculoskeletal and connective tissue disorders | 300 mg/Day Pregabalin | 1 | 12 | 1 |
| other | chest pain | Musculoskeletal and connective tissue disorders | 0 mg/Day Pregabalin (Placebo 1) | 0 | 13 | 0 |
| other | chest pain | Musculoskeletal and connective tissue disorders | 450 mg/Day PregabalinPregabalin | 13 | ||
| other | chest pain | Musculoskeletal and connective tissue disorders | 0 mg/Day Pregabalin (Placebo 2) | 14 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 300 mg/Day Pregabalin | 0 | 12 |
| Total, all-cause mortality | 0 mg/Day Pregabalin (Placebo 1) | 0 | 13 |
| Total, all-cause mortality | 450 mg/Day PregabalinPregabalin | 0 | 13 |
| Total, all-cause mortality | 0 mg/Day Pregabalin (Placebo 2) | 0 | 14 |
| Total, other adverse events | 300 mg/Day Pregabalin | 1 | 12 |
| Total, other adverse events | 0 mg/Day Pregabalin (Placebo 1) | 1 | 13 |
| Total, other adverse events | 450 mg/Day PregabalinPregabalin | 0 | 13 |
| Total, other adverse events | 0 mg/Day Pregabalin (Placebo 2) | 0 | 14 |
| Total, serious adverse events | 300 mg/Day Pregabalin | 0 | 12 |
| Total, serious adverse events | 0 mg/Day Pregabalin (Placebo 1) | 0 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| R01DA036550 | Human Laboratory Screening of Pregabalin and Tiagabine for Cannabis Dependence | LILE, JOSHUA ANTHONY | UNIVERSITY OF KENTUCKY | NATIONAL INSTITUTE ON DRUG ABUSE | 2014 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01511640
GET https://conductscience.org/api/trials/v1/NCT01511640/flow?page=2