Cannabis Use DisorderPhase 2NCT03980561
UH3 Varenicline for Cannabis Use Disorder
A Phase 2 study testing Varenicline in people with Cannabis Use Disorder, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2020to 1 Dec 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.
- Express interest in receiving treatment for cannabis use disorder and reducing use.
- Must be at least 18 years of age.
- If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
- Must consent to random assignment, and be willing to commit to medication ingestion.
- Must be able to read and provide informed consent.
- Must have body weight >110lbs (50kg) and have BMI between 18 and 35kg/m2
- Must function at an intellectual level and have knowledge of the English language to sufficiently allow for accurate completion of assessments.
Who cannot join
- Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
- Individuals with severe renal impairment (creatinine clearance less than 30 mL per minute).
- Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication has been prescribed for at least 2 months prior to screening and no changes in current medication expected during course of the trial).
- Past year or current posttraumatic stress disorder.
- Subjects who are actively suicidal, or who report suicidal ideation (SI) with intent or plan in the past year.
- Subjects who have a SBQ R total score ≥8, or for whom the investigator judges that a risk assessment by a qualified medical professional is required. Subjects answering 'yes' on questions 4 or 5 of C-SSRS will be referred to assessment by a qualified mental health professional.
Show all 21Show fewer
- Suicidal behavior within the past 10 years or a lifetime history of serious or recurrent suicidal behavior.
- Concomitant use of psychotropic medications, with the exception of stable doses (defined as no dosing adjustments in the past two months) of non-MAO-I antidepressants, non-benzodiazepine anxiolytics, and ADHD medications.
- Current use of medications prescribed for mania or psychosis.
- Current use of buproprion or nortryptiline.
- Moderate or severe non-cannabis substance use disorders within the past 60 days with the exception of tobacco use disorder.
- Past year or current moderate or severe alcohol use disorder.
- Individuals taking an investigational agent within the last 30 days before baseline visit.
- Individuals with clinically significant medical disorders or lab abnormalities.
- Any individual at screening with SGOT (AST) or SGPT (ALT) greater than 3 times the upper limit of normal and/or total bilirubin greater than two times the upper limit of normal.
- Individuals with clinically significant cardiovascular disease in the past 6 months (e.g., myocardial infarction, CABG, PTCA, severe or unstable angina, serious arrhythmia, or any clinically significant ECG conduction abnormality.
- Individuals with clinically significant cerebrovascular disease in the past 6 months such as TIA, CVA, or stroke.
- Hypersensitivity to varenicline.
- Individuals who have participated in the clinical trial of any investigative compound within the last 60 days
- Individuals who are on probation or under a mandate to obtain treatment.
- Individuals with plans to initiate or change frequency of attendance at self-help meetings (e.g. AA, NA).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Behavioral Health Services of Pickens County
Pickens, South Carolina, 29671
About this study
Official title: Varenicline for the Treatment of DSM 5 Cannabis Use Disorder in Adults
Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.
- Conditions
- Cannabis Use Disorder
- Being tested
- Varenicline, Placebo
- Keywords
- marijuana, substance use
- Medical subject headings
- Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix, Apo-Varenicline
Active medication
PlaceboDrug
Also called Sugar pill
Inactive medication
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | 2 mg daily Receives: Drug: Varenicline |
| Placebo | Placebo comparator | 2 mg daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.
Measured: Treatment phase Weeks 6-12
Secondary outcomes (1)
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.
Measured: 12 weeks (across the active treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start31 Jan 2020
- Primary completion9 Feb 2023
- Study completion1 Dec 2023
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 Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee McRae-Clark, PharmD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980561
- Sponsor's protocol ID
- PRO00089933
- Status last verified
- Dec 2023
- First submitted
- 6 Jun 2019
- Last updated
- 18 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for the Treatment of DSM 5 Cannabis Use Disorder in Adults
- ClinicalTrials.gov ID
- NCT03980561
- Acronym / sponsor ID
- PRO00089933
- Conditions
- Cannabis Use Disorder
- Keywords
- marijuana, substance use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Posted 18 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: Varenicline2 mg daily |
| Placebo | Placebo comparator | Drug: Placebo2 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.
- Express interest in receiving treatment for cannabis use disorder and reducing use.
- Must be at least 18 years of age.
- If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
- Must consent to random assignment, and be willing to commit to medication ingestion.
Key exclusion criteria (21 listed)
- Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
- Individuals with severe renal impairment (creatinine clearance less than 30 mL per minute).
- Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication has been prescribed for at least 2 months prior to screening and no changes in current medication expected during course of the trial).
- Past year or current posttraumatic stress disorder.
- Subjects who are actively suicidal, or who report suicidal ideation (SI) with intent or plan in the past year.
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 |
|---|---|---|
| VareniclineAlso: Chantix, Apo-VareniclineActive medication | Drug | Varenicline |
| PlaceboAlso: Sugar pillInactive medication | Drug | Placebo |
Primary outcome
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Time frame: Treatment phase Weeks 6-12
Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.
1 secondary outcome
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
Time frame: 12 weeks (across the active treatment period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Aimee McRae-Clark, PharmD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline in people with Cannabis Use Disorder, run by Medical University of South Carolina at 2 sites in United States.
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 21 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2024). 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?
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions (time frame: Treatment phase Weeks 6-12). 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 18 Jan 2024.