Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Tracking Information
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; (submitted: December 30, 2015)	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.
Original Primary Outcome Measures ICMJE; (submitted: December 11, 2012)	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
Change History	Complete list of historical versions of study NCT01748799 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 30, 2015)	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).
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
Condition ICMJE	Cannabis Dependence
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 1, 2014)	16
Original Estimated Enrollment ICMJE; (submitted: December 11, 2012)	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: 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
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Principal Investigator: Bernard Le Foll Centre for Addiction and Mental Health
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