- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04595318
Varenicline for Co-occurring Cannabis and Tobacco Use
April 21, 2021 updated by: Albert Einstein College of Medicine
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 abuse treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Participants were recruited from an urban, outpatient substance abuse treatment program that offers both intensive behavioral counseling and medication-assisted treatment (MAT) for opioid use disorder.
The investigators selected these clinical sites because the investigators have successfully recruited and retained participants from these sites in prior clinical trials, and anticipated that they would find a high prevalence of persons with frequent cannabis use.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unstable medical or psychiatric illness
- Opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard clinical care
Four weeks of medication-assisted treatment (MAT) with standard clinical care (SCC).
MAT includes individual counseling that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance abuse counselors.
|
Standard clinical care includes methadone clinic-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies
|
Active Comparator: Standard clinical care and varenicline
Four weeks of MAT with standard clinical care plus varenicline therapy (SCC and VT).
Varenicline therapy included a one-month 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.
MAT includes individual counseling that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance abuse counselors.
|
Standard clinical care includes methadone clinic-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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrollment rate
Time Frame: Week 8
|
proportion of screened subjects eligible and willing to participate
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention rates of participants
Time Frame: Week 8
|
Retention rate was determined as the proportion of completed study visits.
|
Week 8
|
Medication adherence measured by pill count.
Time Frame: Weeks 2, 4, 6, and 8.
|
Proportion of pills taken as prescribed.
|
Weeks 2, 4, 6, and 8.
|
Incidence of Treatment-Emergent Adverse Events among participants as assessed by participant self-report on a structured questionnaire of common varenicline side effects.
Time Frame: Weeks 2, 4, 6, and 8.
|
Participants self-reported adverse events using a structured questionnaire of common varenicline symptoms.
The questionnaire was developed ad hoc.
|
Weeks 2, 4, 6, and 8.
|
Incidence of Treatment-Emergent psychiatric symptoms reported by participants as measured by the MINI International Neurospsychiatric Interview
Time Frame: Weeks 2, 4, 6, and 8.
|
To address psychiatric symptoms, the MINI International Neuropsychiatric Interview (M.I.N.I) was used.
The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-IV and ICD-10 psychiatric disorders.
|
Weeks 2, 4, 6, and 8.
|
Cannabis craving as measured by the marijuana craving questionnaire.
Time Frame: Weeks 2, 4, 6, and 8.
|
The Marijuana Craving Questionnaire (MCQ) is a valid and reliable, self-report instrument with 47 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree).
The 47 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).
Total possible scores range from 47- 329.
|
Weeks 2, 4, 6, and 8.
|
Cannabis withdrawal as measured by the marijuana withdrawal checklist.
Time Frame: Weeks 2, 4, 6, and 8.
|
Cannabis withdrawal is measured by the 15-item version of the marijuana withdrawal checklist.
In the marijuana withdrawal checklist, respondents rate 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 is obtained by summing the severity ratings.
Total scores range from 0 - 45, with 0 as the least severe score and 45 as the highest score.
|
Weeks 2, 4, 6, and 8.
|
Quantity of past two week cannabis use as measured by the timeline follow back method.
Time Frame: Weeks 2, 4, 6, and 8.
|
Measured using the timeline follow-back method, a method in which participants use a physical calendar to note the number of days over a specified period of time during which they used cannabis.
|
Weeks 2, 4, 6, and 8.
|
Quantity of past two week tobacco use as measured by the timeline follow back method.
Time Frame: Weeks 2, 4, 6, and 8.
|
Measured using the timeline follow-back method, a method in which participants use a physical calendar to note the number of days over a specified period of time during which they used tobacco.
|
Weeks 2, 4, 6, and 8.
|
Frequency of past two week cannabis use as measured by percentage of days self-reported in the timeline follow-back method.
Time Frame: Weeks 2, 4, 6, and 8.
|
Measured using the timeline follow-back method, a method in which participants use a physical calendar to note the number of days over a specified period of time during which they used cannabis.
|
Weeks 2, 4, 6, and 8.
|
Frequency of past two week tobacco use as measured by percentage of days self-reported in the timeline follow-back method.
Time Frame: Weeks 2, 4, 6, and 8.
|
Measured using the timeline follow-back method, a method in which participants use a physical calendar to note the number of days over a specified period of time during which they used tobacco.
|
Weeks 2, 4, 6, and 8.
|
Cannabis abstinence as measured by urine toxicology test.
Time Frame: Weeks 2, 4, 6, and 8.
|
Cannabis abstinence was measured by a urine toxicology test, defined as a tetrahydrocannabinol level less than 50 ng/ml.
Urine samples were analyzed at a commercial laboratory.
|
Weeks 2, 4, 6, and 8.
|
Biochemically verified tobacco abstinence as measured by a Bedfont Smokerlyzer carbon monoxide reader.
Time Frame: Weeks 2, 4, 6, and 8.
|
Tobacco abstinence was assessed via a Bedfont Smokerlyzer carbon monoxide reader and operationalized as a reading of less than 8 p.p.m.
|
Weeks 2, 4, 6, and 8.
|
Cannabis abstinence as measured by timeline follow back method.
Time Frame: Weeks 2, 4, 6, and 8.
|
Measured using the timeline follow-back method, a method in which participants use a physical calendar to note the number of days over a specified period of time during which they used cannabis.
Abstinence was defined as self-reported two-week abstinence.
|
Weeks 2, 4, 6, and 8.
|
Tobacco abstinence as measured by timeline follow back method.
Time Frame: Weeks 2, 4, 6, and 8.
|
Measured using the timeline follow-back method, a method in which participants use a physical calendar to note the number of days over a specified period of time during which they used tobacco.
Abstinence was defined as self-reported two-week abstinence.
|
Weeks 2, 4, 6, and 8.
|
Mean expired carbon monoxide as measured by Bedfont Smokealyzer carbon monoxide reader.
Time Frame: Weeks 2, 4, 6, and 8.
|
Measured by Bedfont Smokealyzer carbon monoxide reader.
|
Weeks 2, 4, 6, and 8.
|
Incidence of Treatment-Emergent suicidal ideation reported by participants as measured by the Columbia Suicide Severity Rating Scale.
Time Frame: Weeks 2, 4, 6, and 8.
|
The Columbia Suicide Severity Rating Scale 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 and 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 last three questions (4,5, 6) indicate high-risk.
|
Weeks 2, 4, 6, and 8.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shadi Nahvi, Montefiore Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
April 28, 2016
First Submitted That Met QC Criteria
October 19, 2020
First Posted (Actual)
October 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-279-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cannabis Dependence
-
University of VirginiaNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Nicotine Dependence | Marijuana Dependence | Cannabis Abuse | Nicotine WithdrawalUnited States
-
Tel-Aviv Sourasky Medical CenterUnknownCannabis Dependence | Psychostimulant DependenceIsrael
-
Centre hospitalier de l'Université de Montréal...RecruitingCannabis | Cannabis Dependence | Cannabis Use | Cannabis Smoking | Cannabis Use, UnspecifiedCanada
-
The Scripps Research InstituteNational Institute on Drug Abuse (NIDA)CompletedAlcohol Dependence | Cannabis Dependence | Alcohol Use Disorder | Cannabis Use DisorderUnited States
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Cannabis Abuse
-
Assistance Publique - Hôpitaux de ParisTerminatedCannabis Dependence | Cannabis AbuseFrance
-
Brown UniversityNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Cannabis AbuseUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence, Continuous | Cannabis Use DisorderUnited States
-
Elias DakwarRecruitingAddiction | Cannabis Dependence | Cannabis Use | Substance Abuse | Cannabis Abuse | Cannabis Use DisorderUnited States
Clinical Trials on Standard clinical care
-
Azienda Ospedaliera Città della Salute e della...University of Turin, ItalyCompleted
-
Rigshospitalet, DenmarkOdense University Hospital; Zealand University HospitalNot yet recruiting
-
University of UtahBaylor College of Medicine; National Institute of Nursing Research (NINR); University... and other collaboratorsCompletedParkinson's DiseaseUnited States
-
Denver Health and Hospital AuthorityAmerican Diabetes AssociationCompletedType 1 Diabetes | Type 2 DiabetesUnited States
-
Medical College of WisconsinThe Cleveland ClinicNot yet recruitingIschemia | Coronary Artery Disease | Heart Failure | Hypertension | Diabetes Mellitus | Cardiomyopathies | Peripheral Artery Disease | CardiotoxicityUnited States
-
Fundación Pública Andaluza Progreso y SaludTelefónica S.A.; Agency of Social Services and Dependency of Andalusia; Salud...UnknownChronic Lung Disease | Chronic Heart DiseaseSpain
-
University of DelawareIndependence Prosthetics-Orthotics, Inc.; Orthotic and Prosthetic Education...CompletedDepression | Low Back Pain | Amputation | Neuropathy;Peripheral | Limb IschemiaUnited States
-
Hasselt UniversityUniversity Hospital, Antwerp; Universiteit Antwerpen; University of RegensburgRecruiting
-
University of MalagaKing's College LondonWithdrawnMild Cognitive ImpairmentSpain
-
University of FloridaBrooks Rehabilitation; Foundation for Physical Therapy ResearchCompletedLow Back Pain | Neck PainUnited States