Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

This study is ongoing, but not recruiting participants.
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: June 25, 2014
Last verified: June 2014

December 8, 2012
June 25, 2014
February 2013
August 2014   (final data collection date for primary outcome measure)
Feasibility [ Time Frame: eight weeks ] [ Designated as safety issue: No ]
Feasibility will be assessed by analysing how many participants can be recruited into the study with a period of one year.
Same as current
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 ] [ Designated as safety issue: No ]
To assess what percentage of the included subjects will complete the full experimental phase
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 conditions 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cannabis Dependence
  • Drug: Sativex
    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 conditions 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).
    Other Name: Delta-9-tetrahydrocannabinol and cannabidiol
  • Drug: Placebo spray
    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 conditions 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).
    Other Name: Ethanol, propylene glycol and peppermint oil with colors
  • Experimental: Fixed dose Sativex
    Participants will be requested to take a fixed dose of Sativex during this condition (40 sprays per day)
    Intervention: Drug: Sativex
  • Experimental: Self-titrated Sativex
    Participants will be requested to self-titrate dosages of Sativex (up to 40 sprays per day)
    Intervention: Drug: Sativex
  • Placebo Comparator: Fixed dose placebo
    Participants will be requested to administer a fixed dose of placebo daily (40 sprays per day)
    Intervention: Drug: Placebo spray
  • Placebo Comparator: Self-titrated placebo
    Participants will be requested to self-titrate dosages of placebo spray (up to 40 sprays per day)
    Intervention: Drug: Placebo spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
September 2014
August 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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01748799
103/2011, 243152
No
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
June 2014

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