Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02836756
Other study ID # 2016-6459
Secondary ID
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. completion date
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05535101 - Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder N/A
Completed NCT03318081 - The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction N/A
Completed NCT03221283 - The Application of Music Therapy in Female Amphetamine Use Disorder N/A
Withdrawn NCT02952196 - Cannabioids as a New Intervention for Amphetamine Dependence Phase 2
Completed NCT02285556 - The Diagnostic Assessment and Intervention Study of Amphetamine Type Stimulus N/A
Completed NCT02713815 - Novel Intervention for Amphetamine-type Stimulants Addiction N/A
Completed NCT00713479 - An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers Phase 1
Completed NCT04993300 - Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction N/A
Completed NCT02950376 - The Novel Addiction Assessment Study in Synthetic Drugs Addiction
Recruiting NCT04531384 - Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders. N/A
Recruiting NCT04687566 - Dextromethorphan, Memantine Monotherapy, or Combined Use of Dextromethorphan and Memantine in Amphetamine Addiction Phase 2/Phase 3