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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medical University of South Carolina
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kevin Gray, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01675661
First received: August 19, 2012
Last updated: June 11, 2014
Last verified: June 2014
  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:


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: January 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCLA Integrated Substance Abuse Programs Recruiting
Los Angeles, California, United States, 90025
Contact: Albert Hasson, MSW    310-267-5224    alhasson@ucla.edu   
Principal Investigator: Larissa Mooney, M.D.         
United States, Connecticut
APT Foundation, Inc. Recruiting
New Haven, Connecticut, United States, 06511
Contact: Stephanie Dwy    203-285-1753    SDwy@aptfoundation.org   
Principal Investigator: Kathleen Carroll, Ph.D.         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40502
Contact: Shanna Babalonis, Ph.D.    859-257-1881    babalonis@uky.edu   
Principal Investigator: Sharon Walsh, Ph.D.         
United States, Oregon
CODA, Inc. Recruiting
Portland, Oregon, United States, 97214
Contact: Victoria Asphaug, MScPH    971-202-7829    VictoriaAsphaug@codainc.org   
Principal Investigator: Katharina Wiest, Ph.D.         
United States, South Carolina
Behavioral Health Services of Pickens County Recruiting
Pickens, South Carolina, United States, 29671
Contact: Elizabeth Chapman, CAC II    864-898-2938    echapman@bhspickens.com   
Principal Investigator: Aimee McRae-Clark, PharmD         
United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Harvir Virk    (210) 562-5400    virk@uthscsa.edu   
Principal Investigator: Jennifer Sharpe Potter, Ph.D., M.P.H.         
Sponsors and Collaborators
Medical University of South Carolina
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: June 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced 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 September 16, 2014