Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment

Cannabis Dependence Clinical Trial

— ACCENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675661
• Other study ID #: CTN-0053
• Secondary ID: U10DA013727UG1DA
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	UCLA Integrated Substance Abuse Programs	Los Angeles	California
United States	APT Foundation, Inc.	New Haven	Connecticut
United States	Behavioral Health Services of Pickens County	Pickens	South Carolina
United States	CODA, Inc.	Portland	Oregon
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

McClure EA, Sonne SC, Winhusen T, Carroll KM, Ghitza UE, McRae-Clark AL, Matthews AG, Sharma G, Van Veldhuisen P, Vandrey RG, Levin FR, Weiss RD, Lindblad R, Allen C, Mooney LJ, Haynes L, Brigham GS, Sparenborg S, Hasson AL, Gray KM. Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network. Contemp Clin Trials. 2014 Nov;39(2):211-23. doi: 10.1016/j.cct.2014.08.011. Epub 2014 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Odds of Negative Urine Cannabinoid Tests During Treatment.	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.	study weeks 2-13