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Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01748799
First received: December 8, 2012
Last updated: December 30, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to to demonstrate the feasibility and tolerability of the use of Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal symptoms, craving scores and cannabis consumption during the study period.

Condition Intervention
Cannabis Dependence
Drug: Sativex
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.


Secondary Outcome Measures:
  • Tolerability of Sativex in Persons That Are Cannabis Dependent [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To assess what number of participants might withdrew due non-tolerability of Sativex

  • Cannabis Withdrawal [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).


Enrollment: 16
Study Start Date: February 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sequence 1
Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors
Sequence 2
Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors
Sequence 3
Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors
Sequence 4
Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors
Sequence 5
Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors
Sequence 6
Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors
Sequence 7
Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors
Sequence 8
Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Name: Ethanol, propylene glycol and peppermint oil with colors

Detailed Description:
This will be a one year pilot/feasibility study, assessing the effects of fixed or self-titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal from cannabis and craving among cannabis dependent subjects. Subjects in this study will undergo an 8-week double-blind, placebo-controlled trial. Subjects will be regular cannabis-users who are not currently seeking treatment for cannabis dependence. Subjects will participate in each of 8 conditions, lasting 5 weekdays each (an ABACADAE study design); four smoke as usual conditions (SAU) and four cannabis abstinence conditions. During each abstinence condition (B, C, D, E conditions), subjects will be allocated to one condition including self-titration of placebo, fixed dose of placebo, self-titration of SATIVEX (up to a max of 40 sprays per day, equal to 108mg THC) or fixed dose of SATIVEX (40 sprays per day). Each medication phase will be followed by a washout period where individuals will be requested to smoke cannabis as usual (A condition). The experimental conditions will be: type of SATIVEX® spray used (active vs placebo), and titration regimen (fixed or self-titrated). This pilot study will allow us to demonstrate the feasibility of our approach and to determine the sample size to use secondarily for a larger study. Our ultimate goal is to determine optimal conditions to use for a subsequent randomized controlled trial assessing the efficacy of SATIVEX® in treatment of Cannabis dependence among treatment-seeking subjects.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-50
  • current cannabis dependence
  • cannabis as primary drug of abuse
  • frequent cannabis use (i.e., at least 5 days per week)
  • have experienced at least 2 withdrawal symptoms during previous cessation periods
  • cannabis use not for medical purposes (i.e., not a government-licensed medical cannabis user)
  • not seeking treatment for cannabis dependence
  • willingness to participate in study protocol

Exclusion Criteria:

  • meet criteria for any psychiatric disorder requiring psychiatric intervention
  • have a history of seizures; c)have known sensitivity to Dronabinol, Cannabidiol, Propylene glycole, Ethanol or peppermint oil (used in Sativex buccal spray
  • suffer from an unstable medical condition
  • currently have physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
  • currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
  • pregnant or breast-feeding
  • hold a job that involves operating heavy machinery
  • currently seeking treatment for cannabis-related problems
  • family history of psychotic symptoms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748799

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Bernard Le Foll Centre for Addiction and Mental Health
  More Information

Additional Information:
Responsible Party: Bernard Le Foll, Head, Translational Addiction Research Laboratory, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01748799     History of Changes
Other Study ID Numbers: 103/2011  243152 
Study First Received: December 8, 2012
Results First Received: August 14, 2015
Last Updated: December 30, 2015
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
Cannabis dependence
Sativex

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Peppermint oil
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Parasympatholytics

ClinicalTrials.gov processed this record on September 23, 2016