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

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
N-Acetylcysteine
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Integrated Substance Abuse Programs
  • APT Foundation, Inc.
  • University of Kentucky
  • CODA, Inc.
  • Behavioral Health Services of Pickens County
  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NAC plus CM

Placebo plus CM

Arm Description

N-acetylcysteine (NAC) plus Contingency Management (CM)

Placebo plus Contingency Management (CM)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2012
Last Updated
April 23, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01675661
Brief Title
Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment
Acronym
ACCENT
Official Title
Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAC plus CM
Arm Type
Active Comparator
Arm Description
N-acetylcysteine (NAC) plus Contingency Management (CM)
Arm Title
Placebo plus CM
Arm Type
Placebo Comparator
Arm Description
Placebo plus Contingency Management (CM)
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Description
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.
Time Frame
study weeks 2-13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin M Gray, MD
Organizational Affiliation
Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Programs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
APT Foundation, Inc.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Facility Name
CODA, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Behavioral Health Services of Pickens County
City
Pickens
State/Province
South Carolina
ZIP/Postal Code
29671
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25179587
Citation
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.
Results Reference
background
PubMed Identifier
35084903
Citation
Borodovsky JT, Sofis MJ, Sherman BJ, Gray KM, Budney AJ. Characterizing cannabis use reduction and change in functioning during treatment: Initial steps on the path to new clinical endpoints. Psychol Addict Behav. 2022 Aug;36(5):515-525. doi: 10.1037/adb0000817. Epub 2022 Jan 27.
Results Reference
derived
PubMed Identifier
34197135
Citation
Sherman BJ, Sofis MJ, Borodovsky JT, Gray KM, McRae-Clark AL, Budney AJ. Evaluating cannabis use risk reduction as an alternative clinical outcome for cannabis use disorder. Psychol Addict Behav. 2022 Aug;36(5):505-514. doi: 10.1037/adb0000760. Epub 2021 Jul 1.
Results Reference
derived
PubMed Identifier
31712969
Citation
Tomko RL, Baker NL, Hood CO, Gilmore AK, McClure EA, Squeglia LM, McRae-Clark AL, Sonne SC, Gray KM. Depressive symptoms and cannabis use in a placebo-controlled trial of N-Acetylcysteine for adult cannabis use disorder. Psychopharmacology (Berl). 2020 Feb;237(2):479-490. doi: 10.1007/s00213-019-05384-z. Epub 2019 Nov 11.
Results Reference
derived
PubMed Identifier
28847455
Citation
Hser YI, Mooney LJ, Huang D, Zhu Y, Tomko RL, McClure E, Chou CP, Gray KM. Reductions in cannabis use are associated with improvements in anxiety, depression, and sleep quality, but not quality of life. J Subst Abuse Treat. 2017 Oct;81:53-58. doi: 10.1016/j.jsat.2017.07.012. Epub 2017 Jul 29.
Results Reference
derived
PubMed Identifier
28623823
Citation
Gray KM, Sonne SC, McClure EA, Ghitza UE, Matthews AG, McRae-Clark AL, Carroll KM, Potter JS, Wiest K, Mooney LJ, Hasson A, Walsh SL, Lofwall MR, Babalonis S, Lindblad RW, Sparenborg S, Wahle A, King JS, Baker NL, Tomko RL, Haynes LF, Vandrey RG, Levin FR. A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults. Drug Alcohol Depend. 2017 Aug 1;177:249-257. doi: 10.1016/j.drugalcdep.2017.04.020. Epub 2017 Jun 10.
Results Reference
derived

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Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment

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