Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

December 30, 2015 updated by: Bernard Le Foll, Centre for Addiction and Mental Health

Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Sequence 1
Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors
OTHER: Sequence 2
Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors
OTHER: Sequence 3
Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors
OTHER: Sequence 4
Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors
OTHER: Sequence 5
Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors
OTHER: Sequence 6
Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors
OTHER: Sequence 7
Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors
OTHER: Sequence 8
Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Drug: Sativex
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
Other Names:
  • Delta-9-tetrahydrocannabinol and cannabidiol
Drug: Placebo
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
Other Names:
  • Ethanol, propylene glycol and peppermint oil with colors

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tolerability of Sativex in Persons That Are Cannabis Dependent
Time Frame: 8 weeks
To assess what number of participants might withdrew due non-tolerability of Sativex
8 weeks
Cannabis Withdrawal
Time Frame: 8 weeks
Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernard Le Foll, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 103/2011
  • 243152 (OTHER_GRANT: Canadian Institutes of Health Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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