Clinical trial NCT01675661: Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment
Official title: Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cannabis Dependence
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-08-30
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Odds of Negative Urine Cannabinoid Tests During Treatment.
timeFrame: study weeks 2-13
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Programs
state: California
city: New Haven
country: United States
facility: APT Foundation, Inc.
state: Connecticut
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Portland
country: United States
facility: CODA, Inc.
state: Oregon
city: Pickens
country: United States
facility: Behavioral Health Services of Pickens County
state: South Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
name: Kevin M Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.