Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment - Full Text View

Purpose

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).

Condition	Intervention	Phase
Cannabis Dependence	Drug: N-Acetylcysteine Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT)

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

The odds of negative urine cannabinoid tests during treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

End-of-treatment cannabis abstinence, measured by negative cannabinoid testing throughout the last two and last four weeks of treatment. [ Time Frame: Weeks 9-12 ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
Odds of negative weekly cannabinoid tests during the first 8 weeks of active treatment [ Time Frame: Weeks 1-8 ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
Two- and four-week abstinence, based on urine cannabinoid tests, anchored at week 8 [ Time Frame: Weeks 5-8 ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
Two- and four-week end-of-treatment abstinence assessed via self-reported abstinence confirmed by negative urine cannabinoid tests [ Time Frame: Weeks 9-12 ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
Other cannabis-related measures (e.g., craving, withdrawal, compulsive use, cannabis-associated problems) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
Other substance use (e.g., cigarettes per day among tobacco smokers) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
Nicotine dependence among tobacco smokers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance
The effect of change in cannabis use on depressive symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The effect of change in cannabis use on anxiety symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The effect of change in cannabis use on sleep quality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The effect of change in cannabis use on quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The relationship between self-report (Timeline Follow-Back) and qualitative urine cannabinoid testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The relationship between self-report (Timeline Follow-Back) and quantitative urine cannabinoid testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The relationship between self-report (Timeline Follow Back) and quantitative urine cannabinoid testing dichotomized using methods described in Schwilke et al., 2011 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2013
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: NAC plus CM N-acetylcysteine (NAC) plus Contingency Management (CM)	Drug: N-Acetylcysteine Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions. Other Name: NAC
Placebo Comparator: Placebo plus CM Placebo plus Contingency Management (CM)	Drug: Placebo Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Must demonstrate understanding of study procedures by correctly answering all questions on consent competency tool

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
Current substance dependence, other than cannabis or nicotine
Urine drug screen positive for any drug of abuse other than cannabis at the randomization visit
Maintenance treatment with buprenorphine or methadone
History of asthma, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675661

Contacts

Contact: Susan Sonne, PharmD

843-792-5221

sonnesc@musc.edu

Sponsors and Collaborators

Medical University of South Carolina

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Kevin M Gray, MD

Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Kevin Gray, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT01675661 History of Changes
Other Study ID Numbers:	CTN-0053
Study First Received:	August 19, 2012
Last Updated:	May 20, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 21, 2013

Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment (ACCENT)