Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

This study has been completed.

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: December 30, 2015

Last verified: October 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2012

Last Updated Date

December 30, 2015

Start Date ^ICMJE

February 2013

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.

Original Primary Outcome Measures ^ICMJE

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

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 Provided

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

Enrollment ^ICMJE

Completion Date

September 2014

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

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

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

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