Cannabioids as a New Intervention for Amphetamine Dependence

NCT02952196 | Withdrawn Phase 2 DMC

• 1 other identifier: 16.181
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amphetamine Addiction

Keywords

Amphetamine; Cannabinoids

Outcome Measures

Primary Outcomes (1)

• assessing amphetamine craving

  using questionnaire to assess craving and taking vital signs

  everyday during the study (that will last 3 days for each participants)

Study Arms (3)

placebo

PLACEBO COMPARATOR

Drug: drug administration

cannabinoid dose 1

EXPERIMENTAL

Drug: drug administration

cannabinoid dose 2

EXPERIMENTAL

Drug: drug administration

Interventions

drug administration DRUG

administering drug to patient with amphetamine addiction

cannabinoid dose 1; cannabinoid dose 2; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Didier Jutras-Aswad, MD, MS

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 23, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)