Cannabioids as a New Intervention for Amphetamine Dependence

NCT ID: NCT02952196

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Amphetamine Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

drug administration

Intervention Type DRUG

administering drug to patient with amphetamine addiction

cannabinoid dose 1

Group Type EXPERIMENTAL

drug administration

Intervention Type DRUG

administering drug to patient with amphetamine addiction

cannabinoid dose 2

Group Type EXPERIMENTAL

drug administration

Intervention Type DRUG

administering drug to patient with amphetamine addiction

Interventions

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drug administration

administering drug to patient with amphetamine addiction

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier Jutras-Aswad, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

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Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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16.181

Identifier Type: -

Identifier Source: org_study_id

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