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

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Cannabis Dependence

Treatments: Drug: placebo; Behavioral: Contingency Management; Drug: N-Acetylcysteine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01005810

19152

R01DA026777 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups, including a placebo group

N-Acetylcysteine

Active Comparator group

Treatment:

Behavioral: Contingency Management

Drug: N-Acetylcysteine

Placebo

Placebo Comparator group

Treatment:

Behavioral: Contingency Management

Drug: placebo