N-acetyl cysteine for Cannabis Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cannabis Use DisorderN-acetyl cysteine - Drug
Eligibility
14 - 21
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether N-acetylcysteine can help reduce cannabis use in youth with cannabis use disorder.

Eligible Conditions
  • Cannabis Use Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Weekly urine cannabinoid tests during 12-week active treatment

Weekly urine cannabinoid tests during 12-week active treatment
Proportion of negative urine cannabinoid tests during treatment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Treatment With N-Acetyl Cysteine
35%Pruritis
10%Nausea
This histogram enumerates side effects from a completed 2017 Phase 1 & 2 trial (NCT02206152) in the Treatment With N-Acetyl Cysteine ARM group. Side effects include: Pruritis with 35%, Nausea with 10%.

Trial Design

2 Treatment Groups

N-acetylcysteine
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

192 Total Participants · 2 Treatment Groups

Primary Treatment: N-acetyl cysteine · Has Placebo Group · Phase 2 & 3

N-acetylcysteine
Drug
Experimental Group · 1 Intervention: N-acetyl cysteine · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral capsule · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cysteine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weekly urine cannabinoid tests during 12-week active treatment

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
838 Previous Clinical Trials
5,378,425 Total Patients Enrolled
Kevin M Gray, MDPrincipal InvestigatorProfessor of Psychiatry and Behavioral Sciences
7 Previous Clinical Trials
886 Total Patients Enrolled

Eligibility Criteria

Age 14 - 21 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person must have used cannabis within the last 30 days and meet the criteria for cannabis use disorder as set out in the DSM-5.
People who want to receive treatment for cannabis use disorder must express some type of interest in it.
Females enrolled in the study must use one of the following birth control methods: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring.
Must be able to understand the study and provide written informed consent.
The person must provide a urine sample that tests positive for cannabinoids in order to be screened.

Who else is applying?

What state do they live in?
South Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Medical University of South Carolina100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%