NCT01748799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

December 8, 2012

Results QC Date

August 14, 2015

Last Update Submit

December 30, 2015

Conditions

Cannabis Dependence

Keywords

Cannabis dependenceSativex

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    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.

    12 months

Secondary Outcomes (2)

  • Tolerability of Sativex in Persons That Are Cannabis Dependent

    8 weeks

  • Cannabis Withdrawal

    8 weeks

Study Arms (8)

Sequence 1

OTHER

Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo

Drug: SativexDrug: Placebo

Sequence 2

OTHER

Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo

Drug: SativexDrug: Placebo

Sequence 3

OTHER

Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex

Drug: SativexDrug: Placebo

Sequence 4

OTHER

Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex

Drug: SativexDrug: Placebo

Sequence 5

OTHER

Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo

Drug: SativexDrug: Placebo

Sequence 6

OTHER

Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex

Drug: SativexDrug: Placebo

Sequence 7

OTHER

Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex

Drug: SativexDrug: Placebo

Sequence 8

OTHER

Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo

Drug: SativexDrug: Placebo

Interventions

SativexDRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Also known as: Delta-9-tetrahydrocannabinol and cannabidiol
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Sequence 7Sequence 8
PlaceboDRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Also known as: Ethanol, propylene glycol and peppermint oil with colors
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Sequence 7Sequence 8

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximolsDronabinolCannabidiolEthanolPropylene Glycolpeppermint oilColor

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic ChemicalsAlcoholsPropylene GlycolsGlycolsLightOptical PhenomenaPhysical Phenomena

Limitations and Caveats

The main limitation is the small sample size. Also our study did not include experimental conditions containing THC alone and CBD alone for comparison. The short duration of the experimental condition is also a limitation.

Results Point of Contact

Title
Bernard Le Foll
Organization
Centre for Addiction and Mental Health (CAMH)
bernard.lefoll@camh.ca
416.535.8501

Study Officials

  • Bernard Le Foll

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Translational Addiction Research Laboratory

Study Record Dates

First Submitted

December 8, 2012

First Posted

December 13, 2012

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 1, 2016

Results First Posted

February 1, 2016

Record last verified: 2015-10

Locations

CA(1)