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

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 3

Conditions

Cannabis Dependence

Treatments

Drug: Placebo

Drug: N-Acetylcysteine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01675661

UG1DA013727 (U.S. NIH Grant/Contract)

CTN-0053

U10DA020024 (U.S. NIH Grant/Contract)

U10DA013045 (U.S. NIH Grant/Contract)

U10DA013727 (U.S. NIH Grant/Contract)

U10DA013732 (U.S. NIH Grant/Contract)

U10DA015831 (U.S. NIH Grant/Contract)

U10DA015815 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

302 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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