Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment

Phase 3

Completed

• Conditions: Cannabis Dependence
• Interventions: Drug: Placebo; Drug: N-Acetylcysteine

• Registration Number: NCT01675661
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).

Detailed Description

The primary objective of this Phase 3 study is to evaluate the impact of NAC 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50). After assessment and inclusion into the study, participants will be randomized to receive a 12-week course of NAC 1200 mg or matched placebo twice daily. All participants will concurrently participate in a twice-weekly contingency management (CM) intervention. Medication management will be conducted weekly throughout treatment by the medical clinician. Urine cannabinoid testing will occur at all visits, and will be used as the primary determinant of cannabis use. Participants will return approximately four weeks after treatment conclusion for evaluation of adverse events with medication discontinuation and sustained treatment effects.

Study Timeline

• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-30
• Study Start: 2014-01
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Results First Submitted: 2017-01-18
• Results First Submitted QC: 2017-01-18
• Results First Posted: 2017-03-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• Age 18-50 years
• Must be able to understand the study and provide written informed consent
• Must meet current DSM-IV criteria for cannabis dependence in the last 30 days
• Must express interest in treatment for cannabis dependence
• Must submit a positive urine cannabinoid test during screening
• Women of child bearing potential must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring

Exclusion Criteria

• Allergy or intolerance to N-Acetylcysteine
• Women who are pregnant or lactating
• Current use of NAC or any supplement containing N-Acetylcysteine (must agree not to take any such supplement throughout study participation)
• Use of carbamazepine or nitroglycerin within 14 days of randomization
• Current enrollment in treatment for cannabis dependence
• Any use of synthetic cannabinoids (such as K2/Spice) in the 30 days prior to screening or during the period between screening and randomization
• Current substance dependence, other than cannabis or nicotine
• Urine drug screen positive for any drug of abuse other than cannabis or amphetamines at the randomization visit (Only participants who have a valid prescription for amphetamines (e.g., for ADHD) may be included)
• Urine drug screen positive for amphetamines at the randomization visit without having a valid prescription for it
• Maintenance treatment with buprenorphine or methadone
• Recent history of asthma (within the last 3 years)
• History of seizure disorder, bipolar disorder, schizophrenia, or other significant or unstable medical or psychiatric illness that may place the participant at increased risk in the judgment of the medical clinician
• Significant risk of homicide or suicide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus CM	Placebo	Placebo plus Contingency Management (CM)
NAC plus CM	N-Acetylcysteine	N-acetylcysteine (NAC) plus Contingency Management (CM)

Primary Outcome Measures

Name	Time	Method
The Odds of Negative Urine Cannabinoid Tests During Treatment.	study weeks 2-13	The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.

Trial Locations

Locations (6)

CODA, Inc.; 🇺🇸 Portland, Oregon, United States

Behavioral Health Services of Pickens County; 🇺🇸 Pickens, South Carolina, United States

UCLA Integrated Substance Abuse Programs; 🇺🇸 Los Angeles, California, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

APT Foundation, Inc.; 🇺🇸 New Haven, Connecticut, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States