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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
History of Changes
December 8, 2012
December 30, 2015
February 2013
September 2014   (Final data collection date for primary outcome measure)
Feasibility [ Time Frame: 12 months ]
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.
  • Feasibility [ Time Frame: eight weeks ]
    Feasibility will be assessed by analysing how many participants can be recruited into the study with a period of one year.
  • Tolerability of Sativex in cannabis dependent participants [ Time Frame: 8 weeks ]
    To assess what percentage of the included subjects will complete the full experimental phase
Complete list of historical versions of study NCT01748799 on ClinicalTrials.gov Archive Site
  • Tolerability of Sativex in Persons That Are Cannabis Dependent [ Time Frame: 8 weeks ]
    To assess what number of participants might withdrew due non-tolerability of Sativex
  • Cannabis Withdrawal [ Time Frame: 8 weeks ]
    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).
Not Provided
Not Provided
Not Provided
 
Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cannabis Dependence
  • 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 1
    Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
  • Sequence 2
    Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
  • Sequence 3
    Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
  • Sequence 4
    Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
  • Sequence 5
    Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
  • Sequence 6
    Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
  • Sequence 7
    Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
  • Sequence 8
    Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
    Interventions:
    • Drug: Sativex
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01748799
103/2011
243152 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
No
Not Provided
Not Provided
Not Provided
Bernard Le Foll, Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Bernard Le Foll Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP