NCT01439828

Brief Summary

The primary purpose is to assess the efficacy in human of N-acetylcysteine versus placebo during 4 weeks in cannabis withdrawal.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 18, 2021

Status Verified

January 1, 2012

Enrollment Period

Same day

First QC Date

September 21, 2011

Last Update Submit

June 14, 2021

Conditions

Cannabis DependenceCannabis Abuse

Keywords

CannabisN-AcetylcysteinDependenceAbuseCravingGenetic

Outcome Measures

Primary Outcomes (1)

  • Success rate of withdrawal defined by a reduction of at least 50% of the rate of urinary carboxy-THC

    at 4 weeks

Secondary Outcomes (4)

  • The success rate of withdrawal defined by a declarative reduction of at least 50% of the cannabis

    at 2, 3 and 6 months

  • The retention rate of withdrawal

    at 6 months

  • The rate of complete cessation of cannabis use

    at 4 weeks and 2, 3 and 6 months.

  • Phenotypic profile (3 major types)

    at Day 28 (end of treatment)

Study Arms (2)

Experimental : N-acetylcystein

EXPERIMENTAL

N-acetylcystein and placebo doses will be increased if craving decreases \<25% compared to the previous visit. The doses start at 200 mg x 4/24h to 800 mg x 4/24h

Drug: N-acetylcystein

Placebo Comparator

PLACEBO COMPARATOR

N-acetylcystein and placebo doses will be increased if craving decreases \<25% compared to the previous visit. The doses start at 200 mg x 4/24h to 800 mg x 4/24h

Drug: N-acetylcystein

Interventions

N-acetylcysteinDRUG

Visit 1: Consent signed. Blood and urine analysis. Questionnaires assessing cannabis and tobacco's craving.N-acetylcystein and placebo doses will be increased if craving decreases \<25% compared to previous visit.The doses start at 200 mg x 4/24h to 800 mg x 4/24h.Visit 2 to 5: Medication safety and cannabis craving and withdrawal assessment during 4 weeks.

Experimental : N-acetylcysteinPlacebo Comparator

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \> 18 year old
  • Not pregnant or breast feeding
  • Cannabis abuse or dependence diagnosis (DSM-IV)
  • Acceptance of the trial and consent signed, validated by ethic committee
  • Patient affiliated to social insurance care

You may not qualify if:

  • Contraindication to N-acetylcystein : allergic to N-acetylcystein, severe allergic illness, PHENYLCETONURIA, lactose intolerance, gastro-duodenal ulcer.
  • Severe somatic disease not stabilized : diabetes, epilepsia, recent myocardial infarcts, asthma.
  • Severe mental disease not stabilized : schizophrenia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Psychiatrie - Hôpital Lariboisière

Paris, 75010, France

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Eric GUILLEM, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 23, 2011

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2015

Last Updated

June 18, 2021

Record last verified: 2012-01

Locations

FR(1)