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Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747850
First Posted: December 12, 2012
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
Results First Submitted: January 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cannabis Dependence
Interventions: Behavioral: Motivational Enhancement/Cognitive Behavioral Therapy
Drug: Sativex
Drug: Placebo spray

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pilot Study

The first five subjects will be treatment-seekers that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.

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

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 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).

Sativex Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of ten to one of the two groups (Sativex vs. placebo) in a double blind manner. There will be a gradual increase of the maximal allowed dose 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 per day at the end of week 2. There will be a total of 12 weeks of drug exposure (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
Placebo Spray

Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy

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 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).


Participant Flow:   Overall Study
    Pilot Study   Sativex   Placebo Spray
STARTED   5   20   20 
COMPLETED   4   13   14 
NOT COMPLETED   1   7   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sativex

Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose 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 per day at the end of week 2. There will be a total of 12 weeks of drug exposure associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.

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 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).

Placebo Spray

Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy

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 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%).

Pilot Study

The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.

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

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 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).

Total Total of all reporting groups

Baseline Measures
   Sativex   Placebo Spray   Pilot Study   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   5   45 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20 100.0%      20 100.0%      5 100.0%      45 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      5  25.0%      6  30.0%      2  40.0%      13  28.9% 
Male      15  75.0%      14  70.0%      3  60.0%      32  71.1% 
Region of Enrollment 
[Units: Participants]
       
Canada   20   20   5   45 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tolerability   [ Time Frame: six months ]

2.  Secondary:   Cannabis Use (in Days)   [ Time Frame: six months ]

3.  Secondary:   Withdrawal   [ Time Frame: six months ]

4.  Secondary:   Cannabis Craving   [ Time Frame: six months ]

5.  Secondary:   Cannabis Use (Grams)   [ Time Frame: six months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jose Trigo
Organization: CAMH
phone: 416.535.8501 ext 30021
e-mail: jose.trigo@camh.ca



Responsible Party: Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01747850     History of Changes
Other Study ID Numbers: 144/2011
R21DA031906 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2012
First Posted: December 12, 2012
Results First Submitted: January 18, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017