Phase 3
Completed N=302
Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment
Cannabis Dependence
Source: ClinicalTrials.gov NCT01675661 ↗
Enrolled (actual)
302
Serious AEs
2.3%
Results posted
Mar 2017
Primary outcomePrimary: The Odds of Negative Urine Cannabinoid Tests During Treatment. — 25; 21; 30; 22 cannabis negative urine tests — p=0.985
◆ Published Evidence
Highly cited
153citations · ~17 / year
A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults.
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).
Linked Publications (5)
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A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults.
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Reductions in cannabis use are associated with improvements in anxiety, depression, and sleep quality, but not quality of life.
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Depressive symptoms and cannabis use in a placebo-controlled trial of N-Acetylcysteine for adult cannabis use disorder.
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Evaluating cannabis use risk reduction as an alternative clinical outcome for cannabis use disorder.
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Characterizing cannabis use reduction and change in functioning during treatment: Initial steps on the path to new clinical endpoints.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Odds of Negative Urine Cannabinoid Tests During Treatment. |
25; 21; 30; 22; 33; 36 | 0.985 |
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
Data sourced from ClinicalTrials.gov (NCT01675661) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.