Tobacco Use DisorderPhase 2Vet CatNCT05294263
Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans
A Phase 2 study testing Varenicline in people with Tobacco Use Disorder and Cannabis Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
After initial eligibility screening, Veterans who use both cannabis and tobacco will be randomly assigned to receive either varenicline (Chantix) or placebo for 12 weeks. Participants will attend weekly visits, in person or remotely, to provide breath and urine samples for testing, fill out questionnaires, and meet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Cannabis Use Disorder
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 17 Jul 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.
- Meet DSM-5 criteria for tobacco use disorder and smoke at least five cigarettes or report vaping 5 mg of nicotine daily.
- Males and female Veterans aged 18 and over.
- Be interested in quitting or reducing cannabis and tobacco use.
- 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.
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- Must be able to read and provide informed consent.
- Must have body weight >110lbs (50kg) and have BMI between 18 and 35 kg/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.
- Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, PTSD, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication/psychotherapy has been prescribed for at least 2 months prior to screening and no changes in current medication/psychotherapy expected during course of the trial).
- Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be at suicidal (answers 'yes' on questions 4 or 5 of C-SSRS) or homicidal risk will be referred to assessment by a mental health professional.
- 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 (these medications may be allowed if used for other indications)
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- Current use of bupropion, amitriptyline or nortryptiline or other medication known to have drug interactions with varenicline
- Moderate or severe non-cannabis substance use disorders within the past 60 days with the exception of tobacco use disorder.
- Individuals taking an investigational agent within the last 30 days before baseline visit.
- Individuals with clinically significant medical disorders or lab abnormalities.
- Individuals with clinically significant cardiovascular disease in the past 6 months (e.g., myocardial infarction, CABG, PTCA, or severe or unstable angina).
- Individuals with clinically significant cerebrovascular disease in the past 6 months such as TIA, CVA, or stroke
- Hypersensitivity to varenicline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
About this study
Official title: Varenicline for Comorbid Tobacco and Cannabis Use in Veterans
After initial eligibility screening, Veterans who use both cannabis and tobacco will be randomly assigned to receive either varenicline (Chantix) or placebo for 12 weeks. Participants will attend weekly visits, in person or remotely, to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.
Read the detailed description
Screening and Eligibility Assessment. Individuals will be screened by the research study intake coordinator. An initial pre-screen focused on inclusion/exclusion psychiatric diagnoses, medical status, current medication regimen, and ability and willingness to commit to completion of study procedures will be used to initially determine potential study eligibility. Interested individuals will be given a full description of the study procedures and asked to read and sign an IRB-approved informed consent form before participating in a detailed, comprehensive screening and assessment phase.
Diagnostic/Descriptive Assessment. The MINI International Neuropsychiatric Interview (MINI) will be used to assess psychiatric and substance use diagnoses. A medical history and physical exam will be conducted to ensure that the individual is eligible to participate. In the event an individual is found to be ineligible to participate in this research protocol, he or she will be given an appropriate referral for further medical care or to an appropriate treatment program. If found eligible, a randomization visit will be scheduled, and ongoing cannabis and tobacco use will be tracked between initial assessment and randomization.
Treatment Assignment. Eligible individuals will be randomized to receive varenicline or matching placebo in a 1:1 manner utilizing a stratified random block design with block sizes of 2, 4 and 6. To achieve treatment balance, randomization will be stratified by gender and presence of comorbid psychiatric conditions (depression, PTSD, etc.) as both have been shown to modify cannabis use. The randomization allocation schedule will be developed by the study statistician (Partially blinded, A/B treatment) and all study staff, the investigative team and participants will remain blinded to study assignment until study completion or an otherwise medical necessity. The study randomization will be reviewed by the study statistician (partially blinded) on a regular basis to ensure that the schedule is being implemented according to plan. Final treatment assignment (A/B) and dispensing will be performed by the VA Investigational Pharmacy, a centralized research pharmacy that manages clinical trial medications. Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period. Medication (varenicline and matching placebo capsules) will be compounded by Pitt Street Pharmacy, a local pharmacy that has been utilized previously by VA investigators. Dr. McRae-Clark holds an IND from the FDA for the use of varenicline in individuals with cannabis use disorder.
Medication Management. Medication Management (MM) is a common-sense, generalizable approach to encourage adherence to medication specifically, and to a treatment plan in general. Once a week, participants will be seen for a brief MM session. Sessions will be focused on (a) developing and maintaining rapport, (b) reviewing AEs and concomitant medications, and (c) discussing progress with medication adherence and cannabis reduction/abstinence. These sessions provide an opportunity to address challenges and help participants devise strategies for success. In some circumstances, when patient visits are not feasible, safe, or are prohibited, such as in the case of a pandemic, MM may be completed remotely by telehealth/phone. Remote sessions will be delivered via standard desk, laptop computer, tablet, or smartphone running VA approved applications, specifically VA Video Connect/Teams.
- Conditions
- Tobacco Use Disorder, Cannabis Use Disorder
- Being tested
- Varenicline, Placebo
- Keywords
- Nicotine, Smoking, Tobacco Use Disorder, Cannabis, Marijuana Abuse, Marijuana Smoking, Cigarettes
- Medical subject headings
- Tobacco Use Disorder, Smoking, Marijuana Abuse, Marijuana Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
Varenicline is a selective nACHr partial agonist of the 4 2 subtype and a full agonist of the 7 subtype
PlaceboDrug
Matching, inactive medication
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period. Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Matching placebo will be administered over the 12-week period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cannabis using day as reported on Timeline Followback
Number of cannabis using days as self-reported on TLFB
Measured: Weeks 6-12
Average number cigarettes smoked per day as reported on Timeline Followback
Average number of cigarettes smoked per day as self-reported on TFLB
Measured: Weeks 6-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start17 Apr 2023
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Why it stopped: Despite the numerous approaches below, we have not been successful in identifying a recruitment pathway that would ensure feasibility of study continuation. We have had multiple meetings with CSR\&D leadership to discuss our study progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind Placebo Controlled Trial: . Eligible individuals will be randomized to receive varenicline or matching placebo in a 1:1 manner utilizing a stratified random block design with block sizes of 2, 4 and 6.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Aimee L. Mcrae-Clark, PharmD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294263
- Sponsor's protocol ID
- NURA-004-21S
- Other IDs
- I01CX002357
- Acronym
- Vet Cat
- Status last verified
- Aug 2024
- First submitted
- 9 Feb 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for Comorbid Tobacco and Cannabis Use in Veterans
- ClinicalTrials.gov ID
- NCT05294263
- Acronym / sponsor ID
- Vet Cat / NURA-004-21S
- Conditions
- Tobacco Use Disorder, Cannabis Use Disorder
- Keywords
- Nicotine, Smoking, Tobacco Use Disorder, Cannabis, Marijuana Abuse, Marijuana Smoking, Cigarettes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Despite the numerous approaches below, we have not been successful in identifying a recruitment pathway that would ensure feasibility of study continuation. We have had multiple meetings with CSR\&D leadership to discuss our study progress
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 24 Mar 2022 (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.
After initial eligibility screening, Veterans who use both cannabis and tobacco will be randomly assigned to receive either varenicline (Chantix) or placebo for 12 weeks. Participants will attend weekly visits, in person or remotely, to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.
Detailed description
Screening and Eligibility Assessment. Individuals will be screened by the research study intake coordinator. An initial pre-screen focused on inclusion/exclusion psychiatric diagnoses, medical status, current medication regimen, and ability and willingness to commit to completion of study procedures will be used to initially determine potential study eligibility. Interested individuals will be given a full description of the study procedures and asked to read and sign an IRB-approved informed consent form before participating in a detailed, comprehensive screening and assessment phase.
Diagnostic/Descriptive Assessment. The MINI International Neuropsychiatric Interview (MINI) will be used to assess psychiatric and substance use diagnoses. A medical history and physical exam will be conducted to ensure that the individual is eligible to participate. In the event an individual is found to be ineligible to participate in this research protocol, he or she will be given an appropriate referral for further medical care or to an appropriate treatment program. If found eligible, a randomization visit will be scheduled, and ongoing cannabis and tobacco use will be tracked between initial assessment and randomization.
Treatment Assignment. Eligible individuals will be randomized to receive varenicline or matching placebo in a 1:1 manner utilizing a stratified random block design with block sizes of 2, 4 and 6. To achieve treatment balance, randomization will be stratified by gender and presence of comorbid psychiatric conditions (depression, PTSD, etc.) as both have been shown to modify cannabis use. The randomization allocation schedule will be developed by the study statistician (Partially blinded, A/B treatment) and all study staff, the investigative team and participants will remain blinded to study assignment until study completion or an otherwise medical necessity. The study randomization will be reviewed by the study statistician (partially blinded) on a regular basis to ensure that the schedule is being implemented according to plan. Final treatment assignment (A/B) and dispensing will be performed by the VA Investigational Pharmacy, a centralized research pharmacy that manages clinical trial medications. Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period. Medication (varenicline and matching placebo capsules) will be compounded by Pitt Street Pharmacy, a local pharmacy that has been utilized previously by VA investigators. Dr. McRae-Clark holds an IND from the FDA for the use of varenicline in individuals with cannabis use disorder.
Medication Management. Medication Management (MM) is a common-sense, generalizable approach to encourage adherence to medication specifically, and to a treatment plan in general. Once a week, participants will be seen for a brief MM session. Sessions will be focused on (a) developing and maintaining rapport, (b) reviewing AEs and concomitant medications, and (c) discussing progress with medication adherence and cannabis reduction/abstinence. These sessions provide an opportunity to address challenges and help participants devise strategies for success. In some circumstances, when patient visits are not feasible, safe, or are prohibited, such as in the case of a pandemic, MM may be completed remotely by telehealth/phone. Remote sessions will be delivered via standard desk, laptop computer, tablet, or smartphone running VA approved applications, specifically VA Video Connect/Teams.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind Placebo Controlled Trial: . Eligible individuals will be randomized to receive varenicline or matching placebo in a 1:1 manner utilizing a stratified random block design with block sizes of 2, 4 and 6.
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: VareniclineVarenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered over the 12-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.
- Meet DSM-5 criteria for tobacco use disorder and smoke at least five cigarettes or report vaping 5 mg of nicotine daily.
- Males and female Veterans aged 18 and over.
- Be interested in quitting or reducing cannabis and tobacco use.
- If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
Key exclusion criteria (13 listed)
- Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
- Individuals with severe renal impairment.
- Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, PTSD, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication/psychotherapy has been prescribed for at least 2 months prior to screening and no changes in current medication/psychotherapy expected during course of the trial).
- Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be at suicidal (answers 'yes' on questions 4 or 5 of C-SSRS) or homicidal risk will be referred to assessment by a mental health professional.
- 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.
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: ChantixVarenicline is a selective nACHr partial agonist of the 4 2 subtype and a full agonist of the 7 subtype | Drug | Varenicline |
| PlaceboMatching, inactive medication | Drug | Placebo |
Primary outcome
Number of cannabis using day as reported on Timeline Followback
Time frame: Weeks 6-12
Number of cannabis using days as self-reported on TLFB
Average number cigarettes smoked per day as reported on Timeline Followback
Time frame: Weeks 6-12
Average number of cigarettes smoked per day as self-reported on TFLB
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 27 Aug 2024.
- Individual participant dataSharing planned: No
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Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
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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 L. Mcrae-Clark, PharmD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site 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 Tobacco Use Disorder and Cannabis Use Disorder, run by VA Office of Research and Development at 1 site 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 9 inclusion and 13 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 27 Aug 2024. 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 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?
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?
Number of cannabis using day as reported on Timeline Followback (time frame: Weeks 6-12). 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 27 Aug 2024.