A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use

NCT04627922

Cannabis Use Tobacco Use Disorder Drug Use Disorder

COMPLETED PHASE4

Cannabis and Tobacco Co-use Study

NCT04228965

Tobacco Use Disorder

COMPLETED PHASE4

Contingency Management for Smoking Abstinence With Adolescent Smokers

NCT01056588

Cigarette Smoking

COMPLETED NA

Young Adult Tobacco/Nicotine and Cannabis Co-use

NCT06239350

Tobacco Use Disorder Nicotine Dependence

RECRUITING NA

Extended Cessation Treatment for Teen Smokers

NCT00459953

Nicotine Dependence

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N-Acetylcysteine

Group Type ACTIVE_COMPARATOR

N-Acetylcysteine

Intervention Type DRUG

1200 mg twice daily for 8 weeks

Contingency Management

Intervention Type BEHAVIORAL

rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2 capsules twice daily for 8 weeks

Contingency Management

Intervention Type BEHAVIORAL

rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-Acetylcysteine

1200 mg twice daily for 8 weeks

Intervention Type DRUG

placebo

2 capsules twice daily for 8 weeks

Intervention Type DRUG

Contingency Management

rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NAC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No