Trial · NCT01347762
Nabilone for Cannabis Dependence: A Pilot Study
NCT01347762, Phase 2, Phase 3, Completed, Mclean Hospital; results first posted 2018-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nabilone for Cannabis Dependence: A Pilot Study. Trials, record NCT01347762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01347762
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nabilone for Cannabis Dependence: A Pilot Study
- NCT number
- NCT01347762
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 84 participants, actual
- Lead sponsor
- Mclean Hospital
- Conditions
- Cannabis Dependence, Marijuana Dependence
- Interventions
- Nabilone, Placebo
- First posted
- 2011-05-04
- Last updated
- 2018-06-01
- Results first posted
- 2018-06-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Cannabis Use at 10 Weeks | baseline and 10 weeks | Quantitative cannabis urine screens (THC-COOH:Creatinine ratio) |
| Primary | Number of Marijuana Inhales Per Day | Week 10 | Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment. |
| Secondary | Change From Baseline Neuropsychological Performance at 4 Weeks | baseline and 4 weeks | performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner |
| Secondary | Change From Baseline Cannabis Use at 14 Weeks | baseline and 14 weeks | quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14) |
| Secondary | Change From Baseline in Neuropsychological Performance at 10 Weeks | baseline and 10 weeks | performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cannabis Use at 10 Weeks | baseline and 10 weeks | Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure. | Ratio | MEAN |
| PRIMARY | Number of Marijuana Inhales Per Day | Week 10 | Fewer participants had their average number of inhales per day analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure. | Inhales per day | MEAN |
| SECONDARY | Change From Baseline Neuropsychological Performance at 4 Weeks | baseline and 4 weeks | Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator. | ||
| SECONDARY | Change From Baseline Cannabis Use at 14 Weeks | baseline and 14 weeks | Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure. | Ratio | MEAN |
| SECONDARY | Change From Baseline in Neuropsychological Performance at 10 Weeks | baseline and 10 weeks | Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Cannabis Use at 10 Weeks | Nabilone Titrated 2 mg Daily (Phase 1) | 268.8 | Standard Deviation 183.0 | Ratio | |
| Change From Baseline in Cannabis Use at 10 Weeks | Placebo (Phase 1) | 286.7 | Standard Deviation 349.7 | Ratio | |
| Change From Baseline in Cannabis Use at 10 Weeks | Nabilone Titrated to 4 mg Daily (Phase 2) | 490.3 | Standard Deviation 615.0 | Ratio | |
| Change From Baseline in Cannabis Use at 10 Weeks | Placebo (Phase 2) | 216.9 | Standard Deviation 188.5 | Ratio | |
| Number of Marijuana Inhales Per Day | Nabilone Titrated 2 mg Daily (Phase 1) | 33.8 | Standard Deviation 31.0 | Inhales per day | |
| Number of Marijuana Inhales Per Day | Placebo (Phase 1) | 22.6 | Standard Deviation 30.6 | Inhales per day | |
| Number of Marijuana Inhales Per Day | Nabilone Titrated to 4 mg Daily (Phase 2) | 15.8 | Standard Deviation 35.6 | Inhales per day | |
| Number of Marijuana Inhales Per Day | Placebo (Phase 2) | 10.6 | Standard Deviation 14.6 | Inhales per day | |
| Change From Baseline Cannabis Use at 14 Weeks | Nabilone Titrated 2 mg Daily (Phase 1) | 524.2 | Standard Deviation 466.2 | Ratio | |
| Change From Baseline Cannabis Use at 14 Weeks | Placebo (Phase 1) | 326.7 | Standard Deviation 403.7 | Ratio |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nabilone Titrated 2 mg Daily (Phase 1) | 10 | |
| Overall Study | STARTED | Placebo (Phase 1) | 8 | |
| Overall Study | STARTED | Nabilone Titrated to 4 mg Daily (Phase 2) | 16 | |
| Overall Study | STARTED | Placebo (Phase 2) | 18 | |
| Overall Study | COMPLETED | Nabilone Titrated 2 mg Daily (Phase 1) | 6 | |
| Overall Study | COMPLETED | Placebo (Phase 1) | 6 | |
| Overall Study | COMPLETED | Nabilone Titrated to 4 mg Daily (Phase 2) | 7 | |
| Overall Study | COMPLETED | Placebo (Phase 2) | 10 | |
| Overall Study | NOT COMPLETED | Nabilone Titrated 2 mg Daily (Phase 1) | 4 | |
| Overall Study | NOT COMPLETED | Placebo (Phase 1) | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nabilone Titrated 2 mg Daily (Phase 1) | 0 | 10 |
| Total, all-cause mortality | Placebo (Phase 1) | 0 | 8 |
| Total, all-cause mortality | Nabilone Titrated to 4 mg Daily (Phase 2) | 0 | 16 |
| Total, all-cause mortality | Placebo (Phase 2) | 0 | 18 |
| Total, other adverse events | Nabilone Titrated 2 mg Daily (Phase 1) | 0 | 10 |
| Total, other adverse events | Placebo (Phase 1) | 0 | 8 |
| Total, other adverse events | Nabilone Titrated to 4 mg Daily (Phase 2) | 0 | 16 |
| Total, other adverse events | Placebo (Phase 2) | 0 | 18 |
| Total, serious adverse events | Nabilone Titrated 2 mg Daily (Phase 1) | 0 | 10 |
| Total, serious adverse events | Placebo (Phase 1) | 0 | 8 |
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 |
|---|---|---|---|---|---|
| K99DA029115 | Nabilone for Cannabis Dependence: Imaging and Neuropsychological Performance | HILL, KEVIN P. | MCLEAN HOSPITAL | NATIONAL INSTITUTE ON DRUG ABUSE | 2011 to 2012 |
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/NCT01347762
GET https://conductscience.org/api/trials/v1/NCT01347762/registered