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Cannabioids as a New Intervention for Amphetamine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952196
Recruitment Status : Withdrawn (Funding)
First Posted : November 2, 2016
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. assessing amphetamine craving [ Time Frame: everyday during the study (that will last 3 days for each participants) ]
    using questionnaire to assess craving and taking vital signs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952196


Locations
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Canada, Quebec
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Didier Jutras-Aswad, MD, MS Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02952196    
Other Study ID Numbers: 16.181
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Amphetamine
Cannabinoids
Additional relevant MeSH terms:
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Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders