A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
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| ClinicalTrials.gov Identifier: NCT01005810 |
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Recruitment Status :
Completed
First Posted : November 1, 2009
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
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Sponsor:
Medical University of South Carolina
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cannabis Dependence | Drug: N-Acetylcysteine Drug: placebo Behavioral: Contingency Management | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Marijuana
Drug Information available for:
Acetylcysteine
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: N-Acetylcysteine |
Drug: N-Acetylcysteine
1200 mg twice daily for 8 weeks
Other Name: NAC Behavioral: Contingency Management rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule |
| Placebo Comparator: Placebo |
Drug: placebo
2 capsules twice daily for 8 weeks Behavioral: Contingency Management rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule |
Primary Outcome Measures :
- Percentage of Negative Urine Cannabinoid Tests During Treatment [ Time Frame: 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 13 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005810
Locations
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29403 | |
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Kevin M Gray, MD | Medical University of South Carolina |
| Responsible Party: | Kevin Gray, MD, Associate Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01005810 |
| Other Study ID Numbers: |
19152 R01DA026777 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 1, 2009 Key Record Dates |
| Results First Posted: | November 21, 2018 |
| Last Update Posted: | November 21, 2018 |
| Last Verified: | November 2018 |
Additional relevant MeSH terms:
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Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents |
Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |