Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01439828
Other study ID # P081120
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 2012
Est. completion date February 2015

Study information

Verified date January 2012
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Introduction:There are few clinical trials on pharmacotherapies in marijuana dependence. There is no randomized and double-blind trial on N-acetylcysteine efficacy in marijuana withdrawal.Aims:The first aim is to assess the efficacy in human (n=150 outpatients) of N-acetylcysteine versus placebo during 4 weeks in cannabis withdrawal.The secondary aims are:a-Assessing the abstinence during the next 5 months of follow-up.b-Assessing the correlations between genetic characteristics: cytochrome CYP2C9 and CYP3A4, CNR1 receptor, Fatty Amide Hydroxylase (FAAH), dopamine DAT transporters and Catechol-O-MéthylTransférase (COMT); and three phenotypes : 1. cannabis level consumption, 2. cannabis abuse and dependence (DSM-IV), and 3. cannabis withdrawal.c-Assessing tobacco consumption (Fagerström test), NICOTINIQUE receptor CHRA3 and cannabis quitting success.Subjects:150 cannabis outpatients, seeking treatment in LARIBOISIERE hospital cannabis setting, to cut down their cannabis use.Inclusion criteria: > 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.Methods:Randomized and double-blind trial.Visit 0: Clinical assessment and trial presentation, Validate inclusion and non- inclusion criteria.Visit 1: Consent signed. Blood and urine analysis. Questionnaires assessing cannabis and tobacco's craving.NAC 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.Visit 5: Blood and urine analysis.Visit 6 to 8: abstinence assessment during 5 months.Goals:Efficacy assessment of N-Acetylcysteine in cannabis withdrawal and abstinence compared to placebo. Assessment of NAC efficacy in cannabis craving. The length of the study is 6 months to evaluate abstinence persistence. Evaluation of clinical, biological and genetic factors associated with abstinence success.Statistic :Sample size : A two group continuity corrected c2 test with a 0.050 two-sided significance level will have 80% power to detect the difference between a Group 1 proportion, p1, of 0.250 and a Group 2 proportion, p2, of 0.500 (odds ratio of 3.000) when the sample size in each group is 66. Taking into account a rate of lost of follow-up around 15 % the total sample size of the study has been fixed at N= 150 patients.Main criterion and binary secondary criteria will be analysed by Chi-square tests or Fisher's exact probability test. Relationships between genotype and phenotypes will be analysed by multivariate logistic models


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date February 2015
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - > 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
N-acetylcystein
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.

Locations

Country Name City State
France Service de Psychiatrie - Hôpital Lariboisière Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of withdrawal defined by a reduction of at least 50% of the rate of urinary carboxy-THC at 4 weeks
Secondary The success rate of withdrawal defined by a declarative reduction of at least 50% of the cannabis at 2, 3 and 6 months
Secondary The retention rate of withdrawal at 6 months
Secondary The rate of complete cessation of cannabis use Declarative clinical criteria by the patient and validated at D28 by the decrease of at least 50% of the report of the dosage of the report CarboxyTHC / creatinine at 4 weeks and 2, 3 and 6 months.
Secondary Phenotypic profile (3 major types) The amount of cannabis and THC consumed with use of the upper quartile to define a high consumption and the lowest quartile to define the weak consumer
Dependence and abuse according to DSM IV criteria;
Withdrawal syndrome in dependent patients according to DSM IV and the scale of MJQQ Gorelick.
at Day 28 (end of treatment)
See also
  Status Clinical Trial Phase
Completed NCT01005810 - A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana Phase 2
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 NCT01834794 - Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders N/A