Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
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ClinicalTrials.gov Identifier: NCT01748799 |
Recruitment Status
:
Completed
First Posted
: December 13, 2012
Results First Posted
: February 1, 2016
Last Update Posted
: February 1, 2016
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Sponsor:
Centre for Addiction and Mental Health
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
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Tracking Information | ||||
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First Submitted Date ICMJE | December 8, 2012 | |||
First Posted Date ICMJE | December 13, 2012 | |||
Results First Submitted Date | August 14, 2015 | |||
Results First Posted Date | February 1, 2016 | |||
Last Update Posted Date | February 1, 2016 | |||
Study Start Date ICMJE | February 2013 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01748799 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Fixed or Self-Titrated Dosages of Sativex on Cannabis Users | |||
Official Title ICMJE | Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users | |||
Brief Summary | 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. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Cannabis Dependence | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
16 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Actual Study Completion Date | September 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01748799 | |||
Other Study ID Numbers ICMJE | 103/2011 243152 ( Other Grant/Funding Number: Canadian Institutes of Health Research ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bernard Le Foll, Centre for Addiction and Mental Health | |||
Study Sponsor ICMJE | Centre for Addiction and Mental Health | |||
Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | |||
Investigators ICMJE |
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PRS Account | Centre for Addiction and Mental Health | |||
Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |