Cannabis DependencePhase 4NCT04595318
Varenicline for Co-occurring Cannabis and Tobacco Use
A Phase 4 study testing Standard clinical care first, followed by standard clinical care and varenicline and Standard clinical care and varenicline first, followed by standard clinical care in people with Cannabis Dependence and Tobacco Dependence, run by Albert Einstein College of Medicine.
Trial summary
Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Dependence, Tobacco Dependence
- What is being tested?
- Standard clinical care first, followed by standard clinical care and varenicline and Standard clinical care and varenicline first, followed by standard clinical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2015
- Phase
- Phase 4
- 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
- Able to speak English
- Uses cannabis at least 5 days in the past 7 days
- Current or former tobacco smoker
- Has not taken varenicline in the past 30 days
- Not pregnant, trying to conceive or breastfeeding
- Able to provide informed consent
- Test positive for cannabinoids by urine toxicology
Who cannot join
- Unstable medical or psychiatric illness
- Opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.
About this study
Official title: Feasibility and Preliminary Effectiveness of Varenicline for Co-occurring Cannabis and Tobacco Use
Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.
Read the detailed description
Treating co-occurring cannabis and tobacco use disorders might reduce the health burdens associated with both substances. However, few studies have evaluated pharmacological interventions, in combination with behavioral treatment, to address co-occurring cannabis and tobacco use; these are limited by high participant attrition, poor adherence to interventions, and lack of control. Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use. Participants were recruited from an urban, outpatient substance use disorder treatment program that offers both intensive behavioral counseling and medications for opioid use disorder (MOUD). Participants were randomized to receive either SCC or SCC and varenicline first and then were crossed over to receive the opposite intervention. The study consisted of two 4-week treatment periods with no washout period. Outcomes are reported in pooled analyses of all participants in each treatment phase.
- Conditions
- Cannabis Dependence, Tobacco Dependence
- Being tested
- Standard clinical care first, followed by standard clinical care and varenicline, Standard clinical care and varenicline first, followed by standard clinical care
- Medical subject headings
- Marijuana Abuse, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard clinical care first, followed by standard clinical care and vareniclineDrug
Also called SCC first, then SCC+VT
Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.
Standard clinical care and varenicline first, followed by standard clinical careDrug
Also called SCC+VT first, then SCC
Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical care first, followed by standard clinical care and varenicline | Experimental | Four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).
This is followed by four weeks of SCC plus varenicline treatment (SCC and VT). Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. Receives: Drug: Standard clinical care first, followed by standard clinical care and varenicline |
| Standard clinical care and varenicline first, followed by standard clinical care | Experimental | Four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days.
This is followed by four weeks of SCC in an outpatient substance use disorder treatment program, as described above. Receives: Drug: Standard clinical care and varenicline first, followed by standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Percentage of the eleven eligible subjects willing to participate
Measured: Baseline
Secondary outcomes (13)
Retention Rate
Retention rate was determined by the percentage of participants who completed all study visits.
Measured: Week 8
Overall Medication Adherence
Overall medication adherence was calculated as a percentage based on the number of pills prescribed during the study, corrected for the number of pills returned, divided by the period (in days), and multiplied by 100. An aggregate percentage of pills was calculated and reported for all seven study participants.
Measured: Upon conclusion of SCC+Varenicline treatment (4 weeks or 8 weeks based on randomization to arm/group)
Number of Participants With Treatment-Emergent Adverse Events: Upset Stomach
The number of participants with a self-reported adverse event of upset stomach was determined using a structured questionnaire of common varenicline symptoms
Measured: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)
Number of Participants With Treatment-Emergent Symptoms of Major Depressive Disorder
The number of participants with self-reported Treatment-Emergent symptoms of major depressive disorder was determined using the MINI International Neuropsychiatric Interview (M.I.N.I), a short structured diagnostic interview tool used to assess DSM-IV and ICD-10 psychiatric disorders
Measured: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)
Cannabis Craving
Cannabis craving was assessed using the Marijuana Craving Questionnaire-Short Form (MCQ-SF). The MCQ-SF is a valid and reliable, self-report instrument with 12 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The 12 items are grouped by certain characteristics and the score of each of resulting groups correlates to the intensity of the four craving dimensions (compulsivity, emotionality, expectancy, and purposefulness). Scores from the four subscales are summed with total possible scores ranging from 12 - 84. Higher scores are indicative of increased craving.
Measured: Week 4 and Week 8
Cannabis Withdrawal
Cannabis withdrawal was measured by the 15-item version of the Marijuana Withdrawal Checklist (MWC). Participants rated each symptom experienced during their most recent period of marijuana abstinence, based on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A total MWC score was obtained by summing the responses. Possible total scoring ranges from 0 - 45, with 0 signifying no withdrawal symptoms and 45 signifying the most severe withdrawal symptoms.
Measured: Week 4 and Week 8
Quantity of Cannabis Use
The quantity of cannabis use over the prior 14-day period was measured using the Timeline Follow-Back (TLFB) method. TLFS is a method in which participants used a physical calendar to quantify the number of days over a specified period of time (in this study 14 days) during which cannabis was used. An aggregate value for percentage of days of cannabis use was calculated by tabulating the total number of days cannabis was used by all study participants over the prior 14-day period and dividing by the total number of calendar days over this period across the 7 participants (i.e., 14x7=98).
Measured: Week 4 and Week 8
Frequency of Cannabis Use
The frequency of cannabis use per day was evaluated over the prior 14-day period using the Timeline Follow-Back method (TLFB), a method in which participants used a physical calendar to self-report the number times per days cannabis was used.
Measured: Week 4 and Week 8
Number of Cigarettes Smoked Per Day
The number of cigarettes smoked per day was measured using Timeline Follow-Back (TLFB). TLFB is a method in which participants used a physical calendar to self-report the number of cigarettes smoked per day over the prior 14-day period in order to evaluate ongoing tobacco usage.
Measured: Week 4 and Week 8
Number of Participants With Toxicology-verified Cannabis Abstinence
The number of participants with Toxicology-verified cannabis abstinence was determined by applying the TLFB method and then biochemically confirming the number of participants with a urine tetrahydrocannabinol (THC) levels less than 50 ng/ml.
Measured: Week 4 and Week 8
Number of Participants With Biochemically-verified Tobacco Abstinence
The number of participants with biochemically-verified tobacco abstinence was determined by applying the TLFB method and then biochemically verified by measuring participant levels of expired carbon monoxide < 8 parts per million (CO < 8ppm). The Bedfont Smokerlyzer carbon monoxide monitor was used in the analysis.
Measured: Week 4 and Week 8
Mean Expired Carbon Monoxide
Mean expired carbon monoxide (CO) per participant was measured using the Bedfont Smokerlyzer carbon monoxide monitor. Results reported in mean parts per million (ppm)
Measured: Week 4 and Week 8
Number of Participants With Treatment-Emergent Suicidal Ideation Events
The number of participants with treatment-emergent suicidal ideation events was determined using the Columbia Suicide Severity Rating Scale (C-SSRS). The C-SSRS contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime as well as during the past 3 months. An answer of "yes" to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of "yes" to questions to the final three questions indicates high-risk.
Measured: Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Shadi Nahvi, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595318
- Sponsor's protocol ID
- 2010-279-12
- Other IDs
- R25GM104547, K23DA025736, R25DA023021
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2016
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of Varenicline for Co-occurring Cannabis and Tobacco Use
- ClinicalTrials.gov ID
- NCT04595318
- Acronym / sponsor ID
- 2010-279-12
- Conditions
- Cannabis Dependence, Tobacco Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of General Medical Sciences (NIGMS)
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.
Detailed description
Treating co-occurring cannabis and tobacco use disorders might reduce the health burdens associated with both substances. However, few studies have evaluated pharmacological interventions, in combination with behavioral treatment, to address co-occurring cannabis and tobacco use; these are limited by high participant attrition, poor adherence to interventions, and lack of control. Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use. Participants were recruited from an urban, outpatient substance use disorder treatment program that offers both intensive behavioral counseling and medications for opioid use disorder (MOUD). Participants were randomized to receive either SCC or SCC and varenicline first and then were crossed over to receive the opposite intervention. The study consisted of two 4-week treatment periods with no washout period. Outcomes are reported in pooled analyses of all participants in each treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard clinical care first, followed by standard clinical care and varenicline | Experimental | Drug: Standard clinical care first, followed by standard clinical care and vareniclineFour weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD). This is followed by four weeks of SCC plus varenicline treatment (SCC and VT). Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. |
| Standard clinical care and varenicline first, followed by standard clinical care | Experimental | Drug: Standard clinical care and varenicline first, followed by standard clinical careFour weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days. This is followed by four weeks of SCC in an outpatient substance use disorder treatment program, as described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to speak English
- Uses cannabis at least 5 days in the past 7 days
- Current or former tobacco smoker
- Has not taken varenicline in the past 30 days
- Not pregnant, trying to conceive or breastfeeding
Key exclusion criteria (2 listed)
- Unstable medical or psychiatric illness
- Opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.
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 |
|---|---|---|
| Standard clinical care first, followed by standard clinical care and vareniclineAlso: SCC first, then SCC+VTStandard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days. | Drug | Standard clinical care first, followed by standard clinical care and varenicline |
| Standard clinical care and varenicline first, followed by standard clinical careAlso: SCC+VT first, then SCCStandard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days. | Drug | Standard clinical care and varenicline first, followed by standard clinical care |
Primary outcome
Enrollment Rate
Time frame: Baseline
Percentage of the eleven eligible subjects willing to participate
13 secondary outcomes
Retention Rate
Time frame: Week 8
Overall Medication Adherence
Time frame: Upon conclusion of SCC+Varenicline treatment (4 weeks or 8 weeks based on randomization to arm/group)
Number of Participants With Treatment-Emergent Adverse Events: Upset Stomach
Time frame: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)
Number of Participants With Treatment-Emergent Symptoms of Major Depressive Disorder
Time frame: Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group)
Cannabis Craving
Time frame: Week 4 and Week 8
Cannabis Withdrawal
Time frame: Week 4 and Week 8
Quantity of Cannabis Use
Time frame: Week 4 and Week 8
Frequency of Cannabis Use
Time frame: Week 4 and Week 8
Number of Cigarettes Smoked Per Day
Time frame: Week 4 and Week 8
Number of Participants With Toxicology-verified Cannabis Abstinence
Time frame: Week 4 and Week 8
Number of Participants With Biochemically-verified Tobacco Abstinence
Time frame: Week 4 and Week 8
Mean Expired Carbon Monoxide
Time frame: Week 4 and Week 8
Number of Participants With Treatment-Emergent Suicidal Ideation Events
Time frame: Week 4 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.
Shadi Nahvi principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard clinical care first, followed by standard clinical care and varenicline and Standard clinical care and varenicline first, followed by standard clinical care in people with Cannabis Dependence and Tobacco Dependence, run by Albert Einstein College of Medicine.
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 7 inclusion and 2 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 24 Sep 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?
Enrollment Rate (time frame: Baseline). 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 24 Sep 2024.