An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents

NCT00542750 | Completed Phase 1 Results DMC

• 2 other identifiers: 5K12 DA 000357 NAC MJ PilotK12DA000357
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.

Conditions

Cannabis Dependence

Keywords

Cannabis; Marijuana; Pharmacotherapy; Adolescent

Outcome Measures

Primary Outcomes (1)

• Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period

  Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.

  one year

Study Arms (1)

N-Acetylcysteine

EXPERIMENTAL

All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated.

Drug: N-Acetylcysteine

Interventions

N-Acetylcysteine DRUG

N-Acetylcysteine 1200 mg twice daily for four weeks

Also known as: GNC brand USP-grade NAC (600 mg capsules)

N-Acetylcysteine

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female, 12 - 20 years old.
• Participants must be regular smokers of marijuana (on average smoke at least 3 times per week for at least one year) and meet DSM-IV Criteria for cannabis dependence, with desire to cut down on marijuana use.
• Participants must understand all oral and written informed consent and give such consent prior to on-site screening.
• Participants must agree to refrain from marijuana use for 24 hours prior to each cue reactivity session (Visits 2 and 4).
• Participants must have a person that can be contacted in case of emergency.
• Participants must have had stable residence for the past 30 days.
• Post-menarchal female participants must agree to use birth control to avoid pregnancy.

You may not qualify if:

• Allergy or intolerance to N-Acetylcysteine (NAC).
• Pregnancy or lactation.
• History of seizures.
• Current or past history of asthma and/or the occasional or daily use of albuterol or other beta-agonist inhalers.
• Current use of medications that might affect heart rate or skin conductance.
• Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study.
• History of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, metabolic, or other disorders that may place the participant at increased risk per the judgment of the study physician.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator
• American Academy of Child Adolescent Psychiatry.: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This was a small, open-label, non-controlled trial, with the associated limitations. A controlled trial is needed to test the effects of N-acetylcysteine relative to placebo.

Results Point of Contact

• Title: Kevin M. Gray, M.D.
• Organization: Medical University of South Carolina

graykm@musc.edu

8437920135

Study Officials

• Kevin M Gray, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 23, 2018
• Results First Posted: May 23, 2018

Record last verified: 2018-04

Locations

US (1)