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

This study is currently recruiting participants.
Verified February 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: February 14, 2014
Last verified: February 2014

August 19, 2012
February 14, 2014
January 2014
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01675661 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 5-8 ] [ 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 ]
Not Provided
Not Provided
 
Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment
Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cannabis Dependence
  • 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
  • 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.
  • Active Comparator: NAC plus CM
    N-acetylcysteine (NAC) plus Contingency Management (CM)
    Intervention: Drug: N-Acetylcysteine
  • Placebo Comparator: Placebo plus CM
    Placebo plus Contingency Management (CM)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Not Provided
United States
 
NCT01675661
CTN-0053
Yes
Kevin Gray, Medical University of South Carolina
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kevin M Gray, MD Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Medical University of South Carolina
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP