Cannabis DependenceNCT01748799
Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
A study testing Sativex in people with Cannabis Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- Sativex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- hold a job that involves operating heavy machinery
- currently seeking treatment for cannabis-related problems
- family history of psychotic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cannabis Dependence
- Being tested
- Sativex, Placebo
- Keywords
- Cannabis dependence, Sativex
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called Delta-9-tetrahydrocannabinol and cannabidiol
All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
PlaceboDrug
Also called Ethanol, propylene glycol and peppermint oil with colors
All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo Receives: Drug: Sativex; Drug: Placebo |
| Sequence 2 | Other | Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo Receives: Drug: Sativex; Drug: Placebo |
| Sequence 3 | Other | Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex Receives: Drug: Sativex; Drug: Placebo |
| Sequence 4 | Other | Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex Receives: Drug: Sativex; Drug: Placebo |
| Sequence 5 | Other | Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo Receives: Drug: Sativex; Drug: Placebo |
| Sequence 6 | Other | Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex Receives: Drug: Sativex; Drug: Placebo |
| Sequence 7 | Other | Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex Receives: Drug: Sativex; Drug: Placebo |
| Sequence 8 | Other | Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo Receives: Drug: Sativex; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Tolerability of Sativex in Persons That Are Cannabis Dependent
To assess what number of participants might withdrew due non-tolerability of Sativex
Measured: 8 weeks
Cannabis Withdrawal
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard Le Foll, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748799
- Sponsor's protocol ID
- 103/2011
- Other IDs
- 243152
- Status last verified
- Oct 2015
- First submitted
- 8 Dec 2012
- Last updated
- 1 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
- ClinicalTrials.gov ID
- NCT01748799
- Acronym / sponsor ID
- 103/2011
- Conditions
- Cannabis Dependence
- Keywords
- Cannabis dependence, Sativex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 1 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: Sativex, Drug: PlaceboSelf-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo |
| Sequence 2 | Other | Drug: Sativex, Drug: PlaceboFixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo |
| Sequence 3 | Other | Drug: Sativex, Drug: PlaceboFixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex |
| Sequence 4 | Other | Drug: Sativex, Drug: PlaceboFixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex |
| Sequence 5 | Other | Drug: Sativex, Drug: PlaceboSelf-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo |
| Sequence 6 | Other | Drug: Sativex, Drug: PlaceboSelf-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex |
| Sequence 7 | Other | Drug: Sativex, Drug: PlaceboSelf-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex |
| Sequence 8 | Other | Drug: Sativex, Drug: PlaceboFixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SativexAlso: Delta-9-tetrahydrocannabinol and cannabidiolAll participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8 |
| PlaceboAlso: Ethanol, propylene glycol and peppermint oil with colorsAll participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8 |
Primary outcome
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.
2 secondary outcomes
Tolerability of Sativex in Persons That Are Cannabis Dependent
Time frame: 8 weeks
Cannabis Withdrawal
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Le Foll principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sativex in people with Cannabis Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.