Trial · NCT00395044
Gabapentin Treatment of Cannabis Dependence
NCT00395044, Phase 2, Completed, The Scripps Research Institute; results first posted 2017-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gabapentin Treatment of Cannabis Dependence. Trials, record NCT00395044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00395044
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gabapentin Treatment of Cannabis Dependence
- NCT number
- NCT00395044
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- The Scripps Research Institute
- Conditions
- Cannabis Dependence
- Interventions
- Placebo, Gabapentin
- First posted
- 2006-11-02
- Last updated
- 2017-02-10
- Results first posted
- 2017-02-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 | Week 0 and Week 12 | Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. |
| Secondary | Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 | Week 0 and Week 12 | The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score). |
| Secondary | Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 | Week 0 and Week 12 | The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score). |
| Secondary | Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 | Week 0 and Week 12 | The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score). |
| Secondary | Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 | Week 0 and Week 12 | The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score). |
| Secondary | Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12 | Week 0 and Week 12 | The MPS is an instrument to assess the incidence of physical, psychological, social, and functioning problems that can result from cannabis dependence. The Total score ranges from 0-38 where 0=best outcome and 38=worst outcome. Change = (Week 12 score - Week 0 score). |
| Secondary | Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4 | Week 0 and Week 4 | The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 | Week 0 and Week 12 | ng/ml | MEAN | |
| SECONDARY | Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 | Week 0 and Week 12 | units on a scale | MEAN | |
| SECONDARY | Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 | Week 0 and Week 12 | units on a scale | MEAN | |
| SECONDARY | Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 | Week 0 and Week 12 | units on a scale | MEAN | |
| SECONDARY | Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 | Week 0 and Week 12 | units on a scale | MEAN | |
| SECONDARY | Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12 | Week 0 and Week 12 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4 | Week 0 and Week 4 | Cognitive testing was done in a subset of participants enrolled in the study, beginning with randomized subject #21 and continuing until the 50th subject was randomized. The number analyzed is the total number available for analysis that completed both the Baseline and Week 4 assessment. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 | Gabapentin | -966.00 | Standard Deviation 1175.25 | ng/ml | |
| Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 | Placebo | -532.81 | Standard Deviation 422.15 | ng/ml | |
| Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 | Gabapentin | 1.42 | Standard Deviation 1.13 | units on a scale | |
| Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 | Placebo | 2.12 | Standard Deviation 1.50 | units on a scale | |
| Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 | Gabapentin | -4.27 | Standard Deviation 3.07 | units on a scale | |
| Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 | Placebo | -1.72 | Standard Deviation 2.80 | units on a scale | |
| Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 | Gabapentin | 3.71 | Standard Deviation 1.98 | units on a scale | |
| Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 | Placebo | 5.22 | Standard Deviation 2.36 | units on a scale | |
| Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 | Gabapentin | -1.55 | Standard Deviation .64 | units on a scale | |
| Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 | Placebo | -1.46 | Standard Deviation .77 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin | 25 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Gabapentin | 7 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Gabapentin | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events22
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 | Gabapentin | 4 | 25 | |
| other | Headache | Nervous system disorders | Placebo | 6 | 25 | |
| other | Insomnia | Nervous system disorders | Gabapentin | 3 | 25 | |
| other | Insomnia | Nervous system disorders | Placebo | 2 | 25 | |
| other | Nausea | Gastrointestinal disorders | Gabapentin | 3 | 25 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 25 | |
| other | Cold symptoms | Respiratory, thoracic and mediastinal disorders | Gabapentin | 2 | 25 | |
| other | Cold symptoms | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 25 | |
| other | Pain | Musculoskeletal and connective tissue disorders | Gabapentin | 0 | 25 | |
| other | Pain | Musculoskeletal and connective tissue disorders | Placebo | 4 | 25 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Gabapentin | 16 | 25 |
| Total, other adverse events | Placebo | 14 | 25 |
| Total, serious adverse events | Gabapentin | 0 | 25 |
| Total, serious adverse events | Placebo | 0 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22373942 | RESULT |
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 |
|---|---|---|---|---|---|
| R21DA020766 | Gabapentin for Cannabis Withdrawal and Use | MASON, BARBARA J | SCRIPPS RESEARCH INSTITUTE, THE | NATIONAL INSTITUTE ON DRUG ABUSE | 2006 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gabapentin vs Placebo: serious adverse events |
Source Trial comparisons
Tests3
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 |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
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/NCT00395044
GET https://conductscience.org/api/trials/v1/NCT00395044/events?page=2