Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Status Completed

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.

Clinical Trial 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 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

Clinical Trial Details

NCT number	NCT01748799
Study type	Interventional
Source	Centre for Addiction and Mental Health
Contact
Status	Completed
Phase	N/A
Start date	February 2013
Completion date	September 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01005810` - A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana	Phase 2
Completed	`NCT00114439` - Lithium Cannabis Withdrawal Study	Phase 2
Completed	`NCT00350285` - The Teen Marijuana Check-Up	Phase 2
Completed	`NCT01618656` - Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal	Phase 2
Completed	`NCT01153490` - Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine	Phase 4
Completed	`NCT02946489` - Facilitating the Behavioral Treatment of Cannabis Use Disorder	Phase 1
Completed	`NCT02088177` - Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence	Phase 1/Phase 2
Not yet recruiting	`NCT01565174` - The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis	N/A
Completed	`NCT01697709` - Quetiapine Pharmacotherapy for Cannabis Dependence	Phase 2
Recruiting	`NCT04721353` - Reducing Cannabis Overuse With Prazosin	Phase 4
Completed	`NCT01603992` - Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms
Completed	`NCT00167297` - Atomoxetine for the Treatment of Cannabis Dependence	Phase 2
Terminated	`NCT01598896` - Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia	Phase 2/Phase 3
Completed	`NCT01611948` - Treatment for Cannabis Withdrawal and Dependence	Phase 2
Recruiting	`NCT03221231` - N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms	Phase 4
Not yet recruiting	`NCT03366909` - Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness	N/A
Completed	`NCT01639872` - Clozapine for Cannabis Use in Schizophrenia	Phase 4
Not yet recruiting	`NCT06334016` - Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream	Early Phase 1
Completed	`NCT01793961` - Effects of Chronic Intake of Cannabis on Contrast Sensitivity	N/A
Completed	`NCT01747850` - Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.