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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


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
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