Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Cannabis Dependence
Interventions
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).

DRUG

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).

Trial Locations (1)

M5S 2S1

Centre for Addiction and Mental Health, Toronto

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Centre for Addiction and Mental Health

OTHER

NCT01747850 - Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence | Biotech Hunter | Biotech Hunter