Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Cannabis Dependence Clinical Trial

Official title:

Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748799
• Other study ID #: 103/2011
• Secondary ID: 243152
• Status: Completed
• Phase: N/A
• First received: December 8, 2012
• Last updated: December 30, 2015
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

Drug:
• Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
• Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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.	12 months	No
Secondary	Tolerability of Sativex in Persons That Are Cannabis Dependent	To assess what number of participants might withdrew due non-tolerability of Sativex	8 weeks	No
Secondary	Cannabis Withdrawal	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).	8 weeks	No

External Links

•   Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre