Trial · NCT01618656
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
NCT01618656, Phase 2, Completed, Yale University; results first posted 2023-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal. Trials, record NCT01618656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01618656
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
- NCT number
- NCT01618656
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Cannabis Dependence
- Interventions
- PF-04457845, Placebo
- First posted
- 2012-06-13
- Last updated
- 2023-02-23
- Results first posted
- 2023-02-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Marijuana Withdrawal Checklist (MWC) | The MWC was administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (during the inpatient phase when withdrawal peaks) to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm. | 32-item checklist evaluating potential symptoms of cannabis withdrawal, lower values reflect lesser severity of withdrawal symptoms (lower scores represent a better outcome). Min: 0 Max: 96 |
| Primary | Change in Self Reported Cannabis Use at the End of 4 Weeks | Administered weekly for 4 weeks to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm. | Subject quantifies and reports frequency of cannabis use prior to study participation and during the 4 week period. Lower scores reflect less cannabis usage, while higher scores reflect more frequent usage. Min: 0 Max: undeterminable, varies per patient and their usage. |
| Primary | Change in THC-COOH Quantification at the End of 4 Weeks | Samples obtained weekly for 4 weeks to assess change from baseline (Day 0). The results from each time point and subject were calculated to report the mean score for each arm. | Subjects provide urine samples to quantify levels of THC. |
| Secondary | Change in Polysomnography | Polysomnography was collected two nights prior to baseline visit, for three nights during study treatment and two nights after four weeks of study treatment. A mean was calculated to assess change from baseline (Day 0). | Polysomnography (PSG) is a comprehensive reading of biophysiological changes that occur during sleep, including identification of sleep stage. A mean and standard deviation of their data points during sleep stages were calculated to determine change from baseline to the end of study treatment. |
| Other | Feeling States | Administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (Once pre-treatment and during the inpatient phase 'acute abstinence') to assess change from baseline (Day 0) | Visual analog scale for feeling states (depression, anxiety, irritability) |
| Other | Plasma Endocannabinoid Levels | Samples obtained at the following study visits: Day -1, Day 0, Day 2, Day 4, Week 2, Week 3, Week 4 to assess change from baseline (Day 0) | Measurement of circulating plasma Anandamide |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Marijuana Withdrawal Checklist (MWC) | The MWC was administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (during the inpatient phase when withdrawal peaks) to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm. | Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable | score on a scale | MEAN |
| PRIMARY | Change in Self Reported Cannabis Use at the End of 4 Weeks | Administered weekly for 4 weeks to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm. | Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable | joints per day | MEAN |
| PRIMARY | Change in THC-COOH Quantification at the End of 4 Weeks | Samples obtained weekly for 4 weeks to assess change from baseline (Day 0). The results from each time point and subject were calculated to report the mean score for each arm. | Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable | ng/mL | MEAN |
| SECONDARY | Change in Polysomnography | Polysomnography was collected two nights prior to baseline visit, for three nights during study treatment and two nights after four weeks of study treatment. A mean was calculated to assess change from baseline (Day 0). | The units analyzed reflects the number of data points (sum of participants per drug condition across time) was 42 in the placebo group and 82 in the PF-04457845 group.~Missing data and the removal of outliers led to differences between the total number of participants and the sample for this variable. | minutes | MEAN |
| OTHER_PRE_SPECIFIED | Feeling States | Administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (Once pre-treatment and during the inpatient phase 'acute abstinence') to assess change from baseline (Day 0) | |||
| OTHER_PRE_SPECIFIED | Plasma Endocannabinoid Levels | Samples obtained at the following study visits: Day -1, Day 0, Day 2, Day 4, Week 2, Week 3, Week 4 to assess change from baseline (Day 0) |
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 |
|---|---|---|---|---|---|
| Change in Marijuana Withdrawal Checklist (MWC) | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 6.04 | 95% Confidence Interval 4.43 to 8.24 | score on a scale | |
| Change in Marijuana Withdrawal Checklist (MWC) | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 11 | 95% Confidence Interval 7.78 to 15.57 | score on a scale | |
| Change in Self Reported Cannabis Use at the End of 4 Weeks | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 0.40 | 95% Confidence Interval 0.25 to 0.62 | joints per day | |
| Change in Self Reported Cannabis Use at the End of 4 Weeks | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 1.27 | 95% Confidence Interval 0.82 to 1.97 | joints per day | |
| Change in THC-COOH Quantification at the End of 4 Weeks | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 265.55 | 95% Confidence Interval 175.60 to 401.57 | ng/mL | |
| Change in THC-COOH Quantification at the End of 4 Weeks | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 657.92 | 95% Confidence Interval 381.60 to 1134.30 | ng/mL | |
| Change in Polysomnography | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 89.56 | Standard Deviation 35.20 | minutes | |
| Change in Polysomnography | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 69.29 | Standard Deviation 27 | minutes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 46 | |
| Overall Study | STARTED | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 24 | |
| Overall Study | COMPLETED | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 38 | |
| Overall Study | COMPLETED | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 20 | |
| Overall Study | NOT COMPLETED | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 8 | |
| Overall Study | NOT COMPLETED | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 4 |
Source ClinicalTrials.gov
Adverse events114
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 | Headache | Nervous system disorders | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 7 | 46 | 12 |
| other | Headache | Nervous system disorders | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 5 | 24 | 8 |
| other | Trouble Concentrating | Nervous system disorders | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 0 | 46 | 0 |
| other | Trouble Concentrating | Nervous system disorders | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 1 | 24 | 1 |
| other | Vomiting | Gastrointestinal disorders | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 1 | 46 | 1 |
| other | Vomiting | Gastrointestinal disorders | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 1 | 24 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 0 | 46 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 1 | 24 | 1 |
| other | Stuffy Nose | General disorders | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 2 | 46 | 2 |
| other | Stuffy Nose | General disorders | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 2 | 24 | 2 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 0 | 46 |
| Total, all-cause mortality | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 0 | 24 |
| Total, other adverse events | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 31 | 46 |
| Total, other adverse events | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 14 | 24 |
| Total, serious adverse events | PF-04457845 (4mg by Mouth Daily for 4 Weeks) | 0 | 46 |
| Total, serious adverse events | Placebo (Sugar Pill, by Mouth Daily for 4 Weeks) | 0 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30528676 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| U01DA033267 | FAAH-Inhibitor for Cannabis Dependence | D'SOUZA, DEEPAK CYRIL | YALE UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2012 to 2015 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PF-04457845 (4mg by Mouth Daily for 4 Weeks) vs Placebo (Sugar Pill, by Mouth Daily for 4 Weeks): deaths from any cause | Trial comparisons |
| PF-04457845 (4mg by Mouth Daily for 4 Weeks) vs Placebo (Sugar Pill, by Mouth Daily for 4 Weeks): serious adverse events | Trial comparisons |
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/NCT01618656
GET https://conductscience.org/api/trials/v1/NCT01618656/events?page=2