Cannabis Use DisorderNCT03629106
Effects of Cannabis Abstinence on Symptomology and Cognition in Bipolar Disorder
A study testing Weekly Behavioral Coaching Session in people with Cannabis Use Disorder and Bipolar Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Bipolar (Type I or II) disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cannabis Use Disorder, Bipolar Disorder, Cognition
- What is being tested?
- Weekly Behavioral Coaching Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants must be between the ages 18-60
- Meet SCID for DSM-5 diagnostic criteria for cannabis use disorder, moderate to severe
- Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder (Type I or II)
- Be an outpatient receiving a stable dose of mood stabilizing medication(s) for at least one month
- Have a Hamilton Depression Rating Scale (HDRS-17) baseline assessment in the range of 12-25
- Have a Full-Scale IQ of at least 80 as determined by the WTAR
Show all 9Show fewer
- Be a non-treatment seeking cannabis user
- Evidence of sufficient motivation and effort as measured by a Test of Memory Malingering (TOMM) score of at least 45
- Y-MRS baseline score in the range of 0-15
Who cannot join
- Meets criteria for abuse or dependence of alcohol or other illicit substances within the past 6 months (with the exception of cannabis, nicotine, or caffeine)
- Positive urine screen for illicit substances other than cannabis, nicotine, or caffeine
- Current suicidal or homicidal ideation
- Psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
- Treatment seeking for cannabis use
- Head Injury > 5 minutes LOC
- Exceed upper and lower cut-offs on HSRD-17 and YMRS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Extended Cannabis Abstinence on Clinical and Cognitive Outcomes in Patients With Co-Morbid Bipolar Disorder and Cannabis Use Disorder
The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Bipolar (Type I or II) disorder. Stabilized bipolar patients (N=52) with CUD will be randomly assigned to one of two groups: 1) A contingent reinforcement (CR) group (n=26); 2) a non-contingent reinforcement (NCR) group (n=26). The study will include a total of 8 visits to the CAMH Russell site (screening, training, baselines, week 1-4, follow-up). Participants should be between the ages of 18-60, meet criteria for CUD (moderate to severe), meet criteria for Bipolar Disorder, be on a stable dose of mood stabilizing medication(s), and be non-treatment seeking cannabis user. The visits will take up a total of approximately 22.5 hours with compensation for time provided for both groups. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement for the CR group.
- Conditions
- Cannabis Use Disorder, Bipolar Disorder, Cognition
- Being tested
- Weekly Behavioral Coaching Session
- Keywords
- Bipolar Disorder, Cannabis Use Disorder, Cognitive Function
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Behavioral Coaching SessionBehavioural
The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.
| Study group | Role | What they receive |
|---|---|---|
| Contingent Reinforcement | Experimental | The Contingent Reinforcement (CR) group (n=26) will be given an abstinence bonus at the successful completion of a 28-Day cannabis abstinence verified by self-report and urinary THC-COOH level <20 ng/ml. Receives: Behavioral: Weekly Behavioral Coaching Session |
| No Contingent Reinforcement | Experimental | The Non-Contingent Reinforcement (NCR) group (n=26) will not be given an abstinence bonus at the successful completion of a 28-Day cannabis abstinence. Receives: Behavioral: Weekly Behavioral Coaching Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with bipolar disorder as assessed by the Hamilton Rating Scale for Depression (HRSD).
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.
Measured: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The effects of 28 day cannabis abstinence on change in hypomania symptoms in cannabis-dependent patients with bipolar disorder as assessed by the Young Mania Rating Scale (YMRS).
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.
Measured: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
Secondary outcomes (2)
The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with bipolar disorder as assessed by a cognitive battery administered at Baseline, Week 2, Endpoint and Follow-Up.
The cognitive battery will include the primary outcome of motivation and effort (assessed by TOMM) and will be compared to baseline (Day 1) performance. Cortical inhibition will also be assessed and compared.
Measured: Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56)
The effects of 28 day cannabis abstinence on change in co-occurring anxiety in cannabis dependent patients with bipolar disorder as assessed by the Beck Anxiety Inventory (BAI).
The clinical assessment will be administered at Baseline, weekly during the abstinence period and Follow-up and will be conducted by study personnel.
Measured: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Oct 2018
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies 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
- Parallel groups
- Model description
- Randomized open-label trial to compare two arms: 1) contingent reinforcement and 2) non-contingent reinforcement.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony George, Centre for Addiction and Mental Health
- Investigators
- Tony George, M.D., FRCPC, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629106
- Sponsor's protocol ID
- 053/2018
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2018
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extended Cannabis Abstinence on Clinical and Cognitive Outcomes in Patients With Co-Morbid Bipolar Disorder and Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT03629106
- Acronym / sponsor ID
- 053/2018
- Conditions
- Cannabis Use Disorder, Bipolar Disorder, Cognition
- Keywords
- Bipolar Disorder, Cannabis Use Disorder, Cognitive Function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid Cannabis Use Disorder (CUD) and Bipolar (Type I or II) disorder. Stabilized bipolar patients (N=52) with CUD will be randomly assigned to one of two groups: 1) A contingent reinforcement (CR) group (n=26); 2) a non-contingent reinforcement (NCR) group (n=26). The study will include a total of 8 visits to the CAMH Russell site (screening, training, baselines, week 1-4, follow-up). Participants should be between the ages of 18-60, meet criteria for CUD (moderate to severe), meet criteria for Bipolar Disorder, be on a stable dose of mood stabilizing medication(s), and be non-treatment seeking cannabis user. The visits will take up a total of approximately 22.5 hours with compensation for time provided for both groups. These visits will involve multiple clinical, substance use, and cognitive assessments. Abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement for the CR group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open-label trial to compare two arms: 1) contingent reinforcement and 2) non-contingent reinforcement.
| Arm | Type | Receives |
|---|---|---|
| Contingent Reinforcement | Experimental | Behavioral: Weekly Behavioral Coaching SessionThe Contingent Reinforcement (CR) group (n=26) will be given an abstinence bonus at the successful completion of a 28-Day cannabis abstinence verified by self-report and urinary THC-COOH level <20 ng/ml. |
| No Contingent Reinforcement | Experimental | Behavioral: Weekly Behavioral Coaching SessionThe Non-Contingent Reinforcement (NCR) group (n=26) will not be given an abstinence bonus at the successful completion of a 28-Day cannabis abstinence. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- All participants must be between the ages 18-60
- Meet SCID for DSM-5 diagnostic criteria for cannabis use disorder, moderate to severe
- Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder (Type I or II)
- Be an outpatient receiving a stable dose of mood stabilizing medication(s) for at least one month
- Have a Hamilton Depression Rating Scale (HDRS-17) baseline assessment in the range of 12-25
Key exclusion criteria (7 listed)
- Meets criteria for abuse or dependence of alcohol or other illicit substances within the past 6 months (with the exception of cannabis, nicotine, or caffeine)
- Positive urine screen for illicit substances other than cannabis, nicotine, or caffeine
- Current suicidal or homicidal ideation
- Psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID
- Treatment seeking for cannabis use
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 |
|---|---|---|
| Weekly Behavioral Coaching SessionThe participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation. | Behavioural | Contingent Reinforcement, No Contingent Reinforcement |
Primary outcome
The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with bipolar disorder as assessed by the Hamilton Rating Scale for Depression (HRSD).
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.
The effects of 28 day cannabis abstinence on change in hypomania symptoms in cannabis-dependent patients with bipolar disorder as assessed by the Young Mania Rating Scale (YMRS).
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
The clinical assessment will be administered weekly during the abstinence period and conducted by study personnel.
2 secondary outcomes
The effects of 28 day cannabis abstinence on change in cognitive function in cannabis dependent patients with bipolar disorder as assessed by a cognitive battery administered at Baseline, Week 2, Endpoint and Follow-Up.
Time frame: Bi-Weekly (Day 0, Day 14, Day 28) and at 8 Weeks (Follow-up Day 56)
The effects of 28 day cannabis abstinence on change in co-occurring anxiety in cannabis dependent patients with bipolar disorder as assessed by the Beck Anxiety Inventory (BAI).
Time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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.
Tony George, M.D., FRCPC 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 Weekly Behavioral Coaching Session in people with Cannabis Use Disorder and Bipolar Disorder, 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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 Sep 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The effects of 28 day cannabis abstinence on change in depressive symptoms in cannabis-dependent patients with bipolar disorder as assessed by the Hamilton Rating Scale for Depression (HRSD). (time frame: Weekly (Day 0, Day 7, Day 14, Day 21, Day 28) and at 8 weeks (Follow-up Day 56)). The study lists 2 primary outcomes in all. 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 11 Sep 2023.