Cannabioids as a New Intervention for Amphetamine Dependence

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02952196

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Addiction to amphetamine is characterized by alternating phases of intoxication and short abstinence, followed by recurrent drug-craving episodes which result in distress and relapse. Addiction involves a number of neurotransmission systems, including the endocannabinoid system (ECBS). It has been demonstarted that cannabidioids can have physiological, anxiolytic and neuroprotective properties. It has been shown to have multiple therapeutic properties for treating anxiety, schizophrenia and interestingly cannabinoids have been shown to be potentially helpful in treating addiction, due to their effects on various neuronal circuits involved in this disorder.

The investigators overall hypothesis is that cannabinoids are an interesting pharmacological contender to decrease amphetamine craving and treat amphetamine addiction.

Condition or Disease	Intervention/Treatment	Phase
Amphetamine Addiction	Drug: drug administration	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Cannabinoids as a New Intervention for Amphetamine Dependence: A Proof-of-concept Study

Anticipated Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo	Drug: drug administration administering drug to patient with amphetamine addiction
Experimental: cannabinoid dose 1	Drug: drug administration administering drug to patient with amphetamine addiction
Experimental: cannabinoid dose 2	Drug: drug administration administering drug to patient with amphetamine addiction

Arm

Intervention/Treatment

Placebo Comparator: placebo

Drug: drug administration

administering drug to patient with amphetamine addiction

Experimental: cannabinoid dose 1

Drug: drug administration

administering drug to patient with amphetamine addiction

Experimental: cannabinoid dose 2

Drug: drug administration

administering drug to patient with amphetamine addiction

Outcome Measures

Primary Outcome Measures

assessing amphetamine craving [everyday during the study (that will last 3 days for each participants)]
using questionnaire to assess craving and taking vital signs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Current DSM-V criteria for amphetamine use disorder
Ability to give valid, informed consent

Exclusion Criteria:

Severe and/or unstable hepatic, neurologic (including diagnosis of seizures), cardiac (including arrhythmias) or renal disease, or any other severe or unstable medical condition that precludes safe participation in the study according to the study physician.
Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or severe suicidality
Any serious medical condition or psychiatric illness that precludes the subject from signing the informed consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier de l'Université de Montréal	Montreal	Quebec	Canada

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Principal Investigator: Didier Jutras-Aswad, MD, MS, Centre hospitalier de l'Université de Montréal (CHUM)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre hospitalier de l'Université de Montréal (CHUM)

ClinicalTrials.gov Identifier:

NCT02952196

Other Study ID Numbers:

16.181

First Posted:

Nov 2, 2016

Last Update Posted:

Oct 23, 2020

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM)

Amphetamine

Cannabinoids

Additional relevant MeSH terms:

Amphetamine-Related Disorders

Study Results

No Results Posted as of Oct 23, 2020