A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
2 other identifiers
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
November 21, 2018
CompletedNovember 21, 2018
November 1, 2018
1.9 years
September 10, 2009
April 23, 2018
November 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
weekly during treatment, for 8 weeks
Study Arms (2)
N-Acetylcysteine
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Eligibility Criteria
You may qualify if:
- Age 13-21 years
- Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kevin M. Gray, Associate Professor
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin M Gray, MD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 10, 2009
First Posted
November 2, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 21, 2018
Results First Posted
November 21, 2018
Record last verified: 2018-11