Cannabioids as a New Intervention for Amphetamine Dependence
Primary Purpose
Amphetamine Addiction
Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
drug administration
Sponsored by
About this trial
This is an interventional prevention trial for Amphetamine Addiction focused on measuring Amphetamine, Cannabinoids
Eligibility 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
Sites / Locations
- Centre hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
placebo
cannabinoid dose 1
cannabinoid dose 2
Arm Description
Outcomes
Primary Outcome Measures
assessing amphetamine craving
using questionnaire to assess craving and taking vital signs
Secondary Outcome Measures
Full Information
NCT ID
NCT02952196
First Posted
October 27, 2016
Last Updated
October 21, 2020
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT02952196
Brief Title
Cannabioids as a New Intervention for Amphetamine Dependence
Official Title
Cannabinoids as a New Intervention for Amphetamine Dependence: A Proof-of-concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
November 2016 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Addiction
Keywords
Amphetamine, Cannabinoids
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
cannabinoid dose 1
Arm Type
Experimental
Arm Title
cannabinoid dose 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
drug administration
Intervention Description
administering drug to patient with amphetamine addiction
Primary Outcome Measure Information:
Title
assessing amphetamine craving
Description
using questionnaire to assess craving and taking vital signs
Time Frame
everyday during the study (that will last 3 days for each participants)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Jutras-Aswad, MD, MS
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cannabioids as a New Intervention for Amphetamine Dependence
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