Trial Outcomes & Findings for An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents (NCT NCT00542750)

Results Overview

Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

one year

Results posted on

2018-05-23

Participant Flow

24 participants were recruited over 9 months in 2008-2009.

After informed consent, an assessment/screening visit was used to determine if prospective participants met criteria for inclusion. Briefly, participants were required to be regular cannabis users meeting current criteria for dependence. Participants with unstable psychiatric or medical issues were excluded.

Participant milestones

Participant milestones
Measure	N-acetylcysteine All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-acetylcysteine n=24 Participants All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	19 years STANDARD_DEVIATION 0.78 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.

Outcome measures

Outcome measures
Measure	N-acetylcysteine n=24 Participants All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period	24 Participants

Adverse Events

N-acetylcysteine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	N-acetylcysteine n=24 participants at risk All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Investigations All	62.5% 15/24 • Number of events 32 • Four weeks (full course of treatment)

Additional Information

Kevin M. Gray, M.D.

Medical University of South Carolina

Phone: 8437920135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place