Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

Cannabis Dependence Clinical Trial

Official title:

Sativex Associated With Behavioral-relapse Prevention Strategy as Treatment for Cannabis Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747850
• Other study ID #: 144/2011
• Secondary ID: R21DA031906
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2012
• Last updated: August 14, 2017
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: July 2017
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to ensure that our planned self-titration regimen is appropriate using Sativex. This phase will be open label, with no placebo control. Then, there will be a twelve-week, double-blind, placebo-controlled study in male and female subjects seeking treatment for cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to come daily to the centre to assess usage of medication. Following the medication phase, participants will have a follow-up weekly for another four weeks and then monthly until the 6 month follow up visit after the target quit date. The investigators are planning to enroll 45 subjects over the two-year period.

Description:

In the pilot study subjects will be treated with SATIVEX® (THC/cannabidiol combination in a buccal spray) using the same approach as outlined below for the randomized controlled trial. In the twelve-week, double-blind, placebo-controlled study visits will occur weekly during the medication phase of the study. The medication will be self-titrated over three weeks and a target quit date will be set up at Day 21. There will be a total of 12 weeks of drug exposure. Throughout these 12-weeks, all participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT) in accordance with the intervention practices shown to be effective in treatment of cannabis dependence. The intervention will be adapted from the Brief Counselling for Marijuana Dependence manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA). At each study visit, vital signs and self-report ratings will be collected. In addition, the subjects will have to come daily to the centre to assess medication usage and will be asked to provide urine sample (two times weekly) and blood sample weekly. As there may be compliance issues, a contingency management approach will be also implemented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult male or female (gender to be analyzed as a covariate)

• Understand and willing to comply with study requirements and restrictions

• Willing to use appropriate contraceptive method throughout the study

• Otherwise healthy as judged by investigator based on medical history, physical exam, vitals, ECG and labs

• DSM-IV criteria for current marijuana dependence

• Report marijuana as primary drug of abuse

• Report using marijuana at least 5 days a week for at least one month

• Have marijuana positive urine drug screen

• Treatment seeking cannabis smoker

• Smoke less than or equal to the equivalent of 4 joints per day (or four grams per day if participants smokes cannabis in other forms)

Exclusion Criteria:

• Meets DSM-IV criteria for a current axis I disorder including substance use disorder other than cannabis, nicotine or caffeine dependence.

• First-degree relative with schizophrenia

• History of seizures

• History of cardiovascular disease

• History of pulmonary disease such as asthma, COPD

• Clinically significant pathology in oral cavity and poor oral hygiene

• Known sensitivity to dronabinol, cannabidiol, propylene glycole, ethanol or peppermint oil (used in SATIVEX® buccal spray)

• Unstable medical conditions

• Pregnant or breast-feeding

• Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia,

• Holding a job that involves driving, operating heavy machines

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

Behavioral:
• Motivational Enhancement/Cognitive Behavioral Therapy
All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.

Drug:
• Sativex
Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). Then exposure to medications will be stopped (so there will be a total of 12 weeks medication treatment exposure).
• Placebo spray
Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure).

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	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability	Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.	six months
Secondary	Cannabis Use (in Days)	The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report)	six months
Secondary	Withdrawal	Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported.; Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal.	six months
Secondary	Cannabis Craving	Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported.; Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana.	six months
Secondary	Cannabis Use (Grams)	Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed	six months

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