Cannabis Dependence
Conditions
Keywords
Cannabis treatment, marijuana treatment
Brief summary
This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Detailed description
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase.
Interventions
DRUGPlacebo
Placebo
DRUGGabapentin
Sponsors
National Institute on Drug Abuse (NIDA)
The Scripps Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males or females age 18-65 with cannabis dependence * Meets DSM-IV-TR criteria for Cannabis Dependence * Smoked marijuana at least once a week in the 90 days prior to study participation * Willing to attend 12 weekly study visits and 1 follow-up visit
Exclusion criteria
* Currently meets DSM-IV-TR criteria for dependence on illicit substances other than cannabis * Significant medical disorders that will increase potential risk or interfere with study participation * Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control * Treatment with an investigational drug in the last month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| 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). |
Countries
United States
Participant flow
Recruitment details
50 subjects were recruited. An initial phone screen was conducted followed by an in-person clinical screening and interview in the research laboratory.
Pre-assignment details
Subjects were excluded from enrollment if they did not meet Inclusion criteria or if they met one or more of the Exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin 1200 mg/daily of Gabapentin | 25 |
| Placebo 1200mg/d of Placebo | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Placebo | Gabapentin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 34.4 years STANDARD_DEVIATION 10.8 | 33.4 years STANDARD_DEVIATION 8.5 | 33.9 years STANDARD_DEVIATION 9.7 |
| Gender Female | 4 Participants | 2 Participants | 6 Participants |
| Gender Male | 21 Participants | 23 Participants | 44 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 25 | 14 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at 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.
Time frame: Week 0 and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 | -966.00 ng/ml | Standard Deviation 1175.25 |
| Placebo | Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 | -532.81 ng/ml | Standard Deviation 422.15 |
p-value: 0.029Mixed Models Analysis
Secondary
Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at 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.
Time frame: Week 0 and Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4 | .28 scores on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4 | -.20 scores on a scale | Standard Deviation 0.31 |
Secondary
Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at 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).
Time frame: Week 0 and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12 | -3.40 units on a scale | Standard Deviation 2.07 |
| Placebo | Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12 | -4.90 units on a scale | Standard Deviation 7.09 |
Secondary
Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at 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).
Time frame: Week 0 and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 | -1.55 units on a scale | Standard Deviation 0.64 |
| Placebo | Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 | -1.46 units on a scale | Standard Deviation 0.77 |
Secondary
Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at 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).
Time frame: Week 0 and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 | 3.71 units on a scale | Standard Deviation 1.98 |
| Placebo | Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 | 5.22 units on a scale | Standard Deviation 2.36 |
Secondary
Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 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).
Time frame: Week 0 and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 | 1.42 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 | 2.12 units on a scale | Standard Deviation 1.5 |
Secondary
Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at 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).
Time frame: Week 0 and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 | -4.27 units on a scale | Standard Deviation 3.07 |
| Placebo | Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 | -1.72 units on a scale | Standard Deviation 2.8 |