- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01747850
Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Sativex Associated With Behavioral-relapse Prevention Strategy as Treatment for Cannabis Dependence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult male or female (gender to be analyzed as a covariate)
- Understand and willing to comply with study requirements and restrictions
- Willing to use appropriate contraceptive method throughout the study
- Otherwise healthy as judged by investigator based on medical history, physical exam, vitals, ECG and labs
- DSM-IV criteria for current marijuana dependence
- Report marijuana as primary drug of abuse
- Report using marijuana at least 5 days a week for at least one month
- Have marijuana positive urine drug screen
- Treatment seeking cannabis smoker
- Smoke less than or equal to the equivalent of 4 joints per day (or four grams per day if participants smokes cannabis in other forms)
Exclusion Criteria:
- Meets DSM-IV criteria for a current axis I disorder including substance use disorder other than cannabis, nicotine or caffeine dependence.
- First-degree relative with schizophrenia
- History of seizures
- History of cardiovascular disease
- History of pulmonary disease such as asthma, COPD
- Clinically significant pathology in oral cavity and poor oral hygiene
- Known sensitivity to dronabinol, cannabidiol, propylene glycole, ethanol or peppermint oil (used in SATIVEX® buccal spray)
- Unstable medical conditions
- Pregnant or breast-feeding
- Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia,
- Holding a job that involves driving, operating heavy machines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sativex
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol).
Study subjects will be randomized in blocks of ten to one of the two groups (Sativex vs. placebo) in a double blind manner.
There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2.
There will be a total of 12 weeks of drug exposure.
All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
|
All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11).
The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to).
The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal).
Then exposure to medications will be stopped (so there will be a total of 12 weeks medication treatment exposure).
Other Names:
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Placebo Comparator: Placebo spray
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11).
The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to).
The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%).
Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure).
Other Names:
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Experimental: Pilot Study
The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label.
These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above.
These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
|
All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11).
The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to).
The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal).
Then exposure to medications will be stopped (so there will be a total of 12 weeks medication treatment exposure).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability
Time Frame: six months
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Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cannabis Use (in Days)
Time Frame: six months
|
The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e.
smoking diary self-report)
|
six months
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Withdrawal
Time Frame: six months
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Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported. Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal. |
six months
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Cannabis Craving
Time Frame: six months
|
Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported. Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana. |
six months
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Cannabis Use (Grams)
Time Frame: six months
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Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed
|
six months
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antiemetics
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Anticonvulsants
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Ethanol
- Peppermint oil
- Dronabinol
- Cannabidiol
- Nabiximols
Other Study ID Numbers
- 144/2011
- R21DA031906 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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