NCT01675661

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 8, 2017

Completed
Last Updated

May 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

August 19, 2012

Results QC Date

January 18, 2017

Last Update Submit

April 23, 2018

Conditions

Cannabis Dependence

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

NAC plus CM

ACTIVE COMPARATOR

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

Drug: N-Acetylcysteine

Placebo plus CM

PLACEBO COMPARATOR

Placebo plus Contingency Management (CM)

Drug: Placebo

Interventions

N-AcetylcysteineDRUG

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.

Also known as: NAC
NAC plus CM
PlaceboDRUG

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.

Placebo plus CM

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCLA Integrated Substance Abuse Programs

Los Angeles, California, 90025, United States

Location

APT Foundation, Inc.

New Haven, Connecticut, 06511, United States

Location

University of Kentucky

Lexington, Kentucky, 40502, United States

Location

CODA, Inc.

Portland, Oregon, 97214, United States

Location

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (6)

  • 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.

    PMID: 25179587BACKGROUND

  • 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.

    PMID: 35084903DERIVED

  • 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.

    PMID: 34197135DERIVED

  • 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.

    PMID: 31712969DERIVED

  • 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.

    PMID: 28847455DERIVED

  • 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.

    PMID: 28623823DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Kevin Gray, MD
Organization
Medical University of South Carolina
graykm@musc.edu
843-792-6330

Study Officials

  • Kevin M Gray, MD

    Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 19, 2012

First Posted

August 30, 2012

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

May 24, 2018

Results First Posted

March 8, 2017

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

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.

Locations

US(6)