Cannabidiol as a New Intervention for Amphetamine Dependence

Amphetamine Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02836756
• Other study ID #: 2016-6459
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 8, 2016
• Last updated: July 14, 2016
• Start date: October 2016

Study information

• Verified date: July 2016
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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). Cannabidiol (CBD), the second most abundant component of cannabis, is known for its broad spectrum of physiological, anxiolytic and neuroprotective properties. It has been shown to have multiple therapeutic properties for treating anxiety, schizophrenia and interestingly CBD has been shown to be potentially helpful in treating addiction, due to its effects on various neuronal circuits involved in this disorder.

Our overall hypothesis is that CBD is an interesting pharmacological contender to decrease amphetamine craving and treat amphetamine addiction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Current DSM-V criteria for amphetamine use disorder

• Current amphetamine use with last use during two weeks prior to admission to the study

• Subject are not under treatment for amphetamine dependence at the time of the study

• 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.

• Hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.

• Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or severe suicidality

• Inability (or unwillingness) of women of childbearing potential to use a medically acceptable form of contraception throughout study duration and for 3 months after dosing stops.

• Couples planning to conceive within the next 12 months.

• Men with history of treatment for fertility problems.

• Another current severe substance use disorder or any substance use disorder that would require pharmacological treatment during the study according to the addiction specialist except nicotine (e.g. benzodiazepine or opiate for alcohol or opioid use disorder)

• Recent cannabis use (in the last week).

• Current regular treatment with psychotropic medications (such as benzodiazepines or anticonvulsants), or opioid medications (including methadone and suboxone) or anticipation that the patient may need to initiate such treatments during the study.

• Any serious medical condition or psychiatric illness that precludes the subject from signing the informed consent form

• To assess whether subjects are normal eligible to participate, they will be asked to fill out a pre-MRI safety screening form and the radiologist's team will assess his/her eligibility.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Amphetamine Addiction
• Amphetamine-Related Disorders

Intervention

Drug:
• CBD
800 or 1600 mg of oral cannabidiol
• Placebo
Oral dose of Placebo
• AMPH
30 mg of oral dextroamphetamine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by the SAFTEE questionnaire and the effect of CBD on brain reactivity to stress and amphetamine cue-induced craving after CBD administration assessed using fMRI technique	SAFTEE questionnaire will assess the safety and tolerability of the two doses of CBD Brain reactivity will be measured during visualization of 1) fearful faces to measure the effect of CBD on stress-induced neuronal reactivity and 2) amphetamine cue-induced craving images to measure the effect of CBD on drug cue-induced craving and neuronal corresponding reactivity.	18 months	Yes