Cannabis Dependence
Conditions
Brief summary
This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.
Detailed description
This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.
Interventions
DRUGN-Acetylcysteine
1200 mg twice daily for 8 weeks
DRUGplacebo
2 capsules twice daily for 8 weeks
BEHAVIORALContingency Management
rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Age 13-21 years * Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment
Exclusion criteria
* Allergy or intolerance to NAC * Pregnancy or lactation * Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation * Current enrollment in treatment for cannabis dependence * Current substance dependence, other than cannabis or nicotine * Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Negative Urine Cannabinoid Tests During Treatment | weekly during treatment, for 8 weeks | \[Total number of negative urine tests per Group divided by the total number of urine tests per Group\]\*100 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-Acetylcysteine N-Acetylcysteine : 1200 mg twice daily for 8 weeks
Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule | 58 |
| Placebo placebo : 2 capsules twice daily for 8 weeks
Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule | 58 |
| Total | 116 |
Baseline characteristics
| Characteristic | Placebo | N-Acetylcysteine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 98 Participants |
| Age, Continuous | 18.8 years STANDARD_DEVIATION 1.5 | 18.9 years STANDARD_DEVIATION 1.5 | 18.9 years STANDARD_DEVIATION 1.5 |
| Region of Enrollment United States | 58 Participants | 58 Participants | 116 Participants |
| Sex: Female, Male Female | 13 Participants | 19 Participants | 32 Participants |
| Sex: Female, Male Male | 45 Participants | 39 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 58 |
| other Total, other adverse events | 24 / 58 | 27 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
Primary
Percentage of Negative Urine Cannabinoid Tests During Treatment
\[Total number of negative urine tests per Group divided by the total number of urine tests per Group\]\*100
Time frame: weekly during treatment, for 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N-Acetylcysteine | Percentage of Negative Urine Cannabinoid Tests During Treatment | 40.9 percentage of negative urine tests |
| Placebo | Percentage of Negative Urine Cannabinoid Tests During Treatment | 27.2 percentage of negative urine tests |
p-value: 0.02995% CI: [1.05, 5.24]Regression, Logistic