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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin Gray, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01675661
First received: August 19, 2012
Last updated: March 7, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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: 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.


Secondary Outcome Measures:
  • End-of-treatment Cannabis Abstinence, Measured by Negative Cannabinoid Testing for the Last Four Weeks of Treatment. [ Time Frame: Study Days 57-84 ]
    This outcome evaluates just the last four weeks of treatment. The outcome measure is again number of negative urine tests for cannabinoids during just the last 4 weeks

  • Effect of Baseline Smoking Status on Cannabis Negative Urine Drug Screens [ Time Frame: Study weeks 2-13 ]
    Outcome was also tested based on whether the participant identified themselves as a tobacco smoker at baseline.

  • Quality of Life [ Time Frame: 12 weeks ]
    Outcome will also be tested among the subgroup of participants that meet criteria for medication compliance


Enrollment: 302
Study Start Date: January 2014
Study Completion Date: August 2015
Primary Completion Date: July 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Los Angeles, California, United States, 90025
United States, Connecticut
APT Foundation, Inc.
New Haven, Connecticut, United States, 06511
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40502
United States, Oregon
CODA, Inc.
Portland, Oregon, United States, 97214
United States, South Carolina
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
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

Publications:
Responsible Party: Kevin Gray, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01675661     History of Changes
Other Study ID Numbers: CTN-0053
U10DA013727 ( US NIH Grant/Contract Award Number )
UG1DA013727 ( US NIH Grant/Contract Award Number )
U10DA013045 ( US NIH Grant/Contract Award Number )
U10DA015815 ( US NIH Grant/Contract Award Number )
U10DA013732 ( US NIH Grant/Contract Award Number )
U10DA015831 ( US NIH Grant/Contract Award Number )
U10DA020024 ( US NIH Grant/Contract Award Number )
Study First Received: August 19, 2012
Results First Received: January 18, 2017
Last Updated: March 7, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: The lead investigator will submit coded individual level data on Clinical Trials Network (CTN) study participants to the Data Management Center contracted by NIDA Center for CTN. These data may include but are not limited to: demographic information, date of birth, medical history, substance use history, psychiatric history, objective measures of substance use and psychiatric status, HIV status and genetic information. Data will be submitted without information that could readily identify the study participant (i.e. We will not share medical record numbers, social security numbers or participant names or phone numbers with the Data Management Center). De-identified data will be made publicly available per the CTN's policies.

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
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 April 25, 2017