Cannabis Dependence, Cannabis Withdrawal, Cognitive Deficits
Conditions
Keywords
Cannabis Treatment, Cannabis Use, Cannabis Dependence, Executive Functioning, Cognitive Deficits
Brief summary
This is a clinical 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 study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.
Interventions
DRUGgabapentin 1200mg/day
gabapentin 1200mg/day for 12 weeks
DRUGPlacebo
1200mg/day of placebo for 12 weeks
BEHAVIORALManual-guided behavioral counseling
Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
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 from 18-65 years of age * Meets DSM IV criteria for current cannabis dependence * Seeking research-based outpatient treatment for cannabis dependence that involves daily medication * Smoked MJ daily at least 25 days per month during the 90 days prior to randomization * At least a 2-year history of regular MJ use
Exclusion criteria
* Abstinent from cannabis more than 2 days at the time of randomization * Active suicidal ideation * Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine * Significant medical disorders that will increase potential risk or interfere with study participation, * Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control * Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence, * Inability to understand and/or comply with the provisions of the protocol and consent form * Treatment with an investigational drug during the previous month * Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients * Ongoing treatment with medications that may affect study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | 12 weeks | Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin 1200mg/Day 1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling. | 75 |
| Placebo Matched placebo given in conjunction with standardized manual-guided behavioral counseling. | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Gabapentin 1200mg/Day | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 34.99 years STANDARD_DEVIATION 10.68 | 34.53 years STANDARD_DEVIATION 11.99 | 34.76 years STANDARD_DEVIATION 11.32 |
| Sex: Female, Male Female | 23 Participants | 27 Participants | 50 Participants |
| Sex: Female, Male Male | 52 Participants | 48 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 75 | 50 / 75 |
| serious Total, serious adverse events | 0 / 150 | 1 / 150 |
Outcome results
Primary
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
Time frame: 12 weeks
Population: Two participants in the gabapentin group and one in the placebo group were lost to follow up after randomization and did not submit any UDS for testing while on study. Two participants in the placebo group withdrew from the study at the week 1 visit, and thus did not submit any UDS for testing while on study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin 1200mg/Day | Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | % Negative UDS ITT | 11.22 percentage of negative UDS | Standard Deviation 21.77 |
| Gabapentin 1200mg/Day | Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | % Negative UDS Observed | 12.48 percentage of negative UDS | Standard Deviation 23.82 |
| Placebo | Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | % Negative UDS ITT | 8.00 percentage of negative UDS | Standard Deviation 19.83 |
| Placebo | Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | % Negative UDS Observed | 9.93 percentage of negative UDS | Standard Deviation 24.03 |