Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01005810
Other study ID # 19152
Secondary ID R01DA026777
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2009
Est. completion date August 2011

Study information

Verified date November 2018
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.


Description:

This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 13 Years to 21 Years
Eligibility Inclusion Criteria:

- Age 13-21 years

- Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment

Exclusion Criteria:

- Allergy or intolerance to NAC

- Pregnancy or lactation

- Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation

- Current enrollment in treatment for cannabis dependence

- Current substance dependence, other than cannabis or nicotine

- Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
N-Acetylcysteine
1200 mg twice daily for 8 weeks
placebo
2 capsules twice daily for 8 weeks
Behavioral:
Contingency Management
rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Negative Urine Cannabinoid Tests During Treatment [Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100 weekly during treatment, for 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT00114439 - Lithium Cannabis Withdrawal Study Phase 2
Completed NCT00350285 - The Teen Marijuana Check-Up Phase 2
Completed NCT01618656 - Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal Phase 2
Completed NCT01153490 - Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine Phase 4
Completed NCT02946489 - Facilitating the Behavioral Treatment of Cannabis Use Disorder Phase 1
Completed NCT02088177 - Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence Phase 1/Phase 2
Not yet recruiting NCT01565174 - The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis N/A
Completed NCT01697709 - Quetiapine Pharmacotherapy for Cannabis Dependence Phase 2
Recruiting NCT04721353 - Reducing Cannabis Overuse With Prazosin Phase 4
Completed NCT01603992 - Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms
Completed NCT00167297 - Atomoxetine for the Treatment of Cannabis Dependence Phase 2
Terminated NCT01598896 - Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia Phase 2/Phase 3
Completed NCT01611948 - Treatment for Cannabis Withdrawal and Dependence Phase 2
Recruiting NCT03221231 - N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms Phase 4
Not yet recruiting NCT03366909 - Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness N/A
Completed NCT01639872 - Clozapine for Cannabis Use in Schizophrenia Phase 4
Not yet recruiting NCT06334016 - Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream Early Phase 1
Completed NCT01793961 - Effects of Chronic Intake of Cannabis on Contrast Sensitivity N/A
Completed NCT01747850 - Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence Phase 2
Completed NCT01834794 - Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders N/A