An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: American Academy of Child Adolescent Psychiatry.; National Institute on Drug Abuse (NIDA)
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Male or female, 12 - 20 years old.

• Participants must be regular smokers of marijuana (on average smoke at least 3 times per week for at least one year) and meet DSM-IV Criteria for cannabis dependence, with desire to cut down on marijuana use.

• Participants must understand all oral and written informed consent and give such consent prior to on-site screening.

• Participants must agree to refrain from marijuana use for 24 hours prior to each cue reactivity session (Visits 2 and 4).

• Participants must have a person that can be contacted in case of emergency.

• Participants must have had stable residence for the past 30 days.

• Post-menarchal female participants must agree to use birth control to avoid pregnancy.

Exclusion Criteria:

• Allergy or intolerance to N-Acetylcysteine (NAC).

• Pregnancy or lactation.

• History of seizures.

• Current or past history of asthma and/or the occasional or daily use of albuterol or other beta-agonist inhalers.

• Current use of medications that might affect heart rate or skin conductance.

• Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study.

• History of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, metabolic, or other disorders that may place the participant at increased risk per the judgment of the study physician.