Smoking CessationPhase 4NCT01027754
Smoking Cessation Treatment for Methadone Maintenance Patients
A Phase 4 study testing Varenicline in people with Smoking Cessation and Substance-Related Disorders, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Substance-Related Disorders
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2011
- 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
- Age 18 or older
- English speaking
- Smoked at least 100 cigarettes/lifetime
- Smokes 5 or more cigarettes per day
- Interested in quitting smoking (preparation or contemplation state of change)
- Enrolled in Einstein/Montefiore methadone program for 3 or more months
Show all 10Show fewer
- Stable methadone dose for 2 weeks
- Agree to use contraception throughout the trial (among women with reproductive potential)
- Willing to participate in all study components
- Able to provide informed consent
Who cannot join
- Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
- Psychiatric instability
- Women who are pregnant, breastfeeding, or contemplating pregnancy
- Creatinine clearance less than 30 mL/min
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine of Yeshiva University
The Bronx, New York, 10467
About this study
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
Read the detailed description
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
- Conditions
- Smoking Cessation, Substance-Related Disorders
- Being tested
- Varenicline, Placebo
- Keywords
- methadone maintenance
- Medical subject headings
- Smoking Cessation, 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
Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
PlaceboDrug
Also called Matched capsules
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Measured: Week 12
Secondary outcomes (14)
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Measured: Week 24
Number of Counseling Visits Completed
Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.
Measured: End of 12 week intervention period
Number of Study Visits Completed
Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24.
Measured: 24 weeks
7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.
Threshold of salivary cotinine ≤ 15 ng/ml was prespecified. Salivary cotinine was measured among participants who self-reported 7-day point prevalence abstinence using a semi-quantitative assay (Nymox NicAlert™).
Measured: Weeks 2, 4, 8, 12, and 24
Number of Cigarettes Smoked Per Day
Measured: Weeks 2, 4, 8, 12, and 24
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
Measured: Weeks 2, 4, 8, 12, and 24
Confidence in Quitting Smoking (1-10 Scale)
Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).
Measured: Weeks 2, 4, 8, 12, and 24
Importance of Quitting Smoking (1-10 Scale)
Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).
Measured: Weeks 2, 4, 8, 12, and 24
Adverse Medication Effects
Measured: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Measured: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Measured: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Measured: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Measured: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Measured: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Shadi Nahvi, M.D., M.S., Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027754
- Sponsor's protocol ID
- 2008-537
- Other IDs
- UL1RR025750
- Status last verified
- May 2021
- First submitted
- 7 Dec 2009
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273Nahvi S, Ning Y, Segal KS, Richter KP, Arnsten JH. Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial. Addiction. 2014 Sep;109(9):1554-63. doi: 10.1111/add.12631. Epub 2014 Jun 27.
PubMed 24862167
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Treatment for Methadone Maintenance Patients
- ClinicalTrials.gov ID
- NCT01027754
- Acronym / sponsor ID
- 2008-537
- Conditions
- Smoking Cessation, Substance-Related Disorders
- Keywords
- methadone maintenance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
Detailed description
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: VareniclineDrug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or older
- English speaking
- Smoked at least 100 cigarettes/lifetime
- Smokes 5 or more cigarettes per day
- Interested in quitting smoking (preparation or contemplation state of change)
Key exclusion criteria (4 listed)
- Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
- Psychiatric instability
- Women who are pregnant, breastfeeding, or contemplating pregnancy
- Creatinine clearance less than 30 mL/min
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: ChantixDays 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day | Drug | Varenicline |
| PlaceboAlso: Matched capsulesDays 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily | Drug | Placebo |
Primary outcome
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time frame: Week 12
14 secondary outcomes
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time frame: Week 24
Number of Counseling Visits Completed
Time frame: End of 12 week intervention period
Number of Study Visits Completed
Time frame: 24 weeks
7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.
Time frame: Weeks 2, 4, 8, 12, and 24
Number of Cigarettes Smoked Per Day
Time frame: Weeks 2, 4, 8, 12, and 24
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
Time frame: Weeks 2, 4, 8, 12, and 24
Confidence in Quitting Smoking (1-10 Scale)
Time frame: Weeks 2, 4, 8, 12, and 24
Importance of Quitting Smoking (1-10 Scale)
Time frame: Weeks 2, 4, 8, 12, and 24
Adverse Medication Effects
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 24862167Nahvi S, Ning Y, Segal KS, Richter KP, Arnsten JH. Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial. Addiction. 2014 Sep;109(9):1554-63. doi: 10.1111/add.12631. Epub 2014 Jun 27.
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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, M.D., M.S. principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Smoking Cessation and Substance-Related Disorders, run by Albert Einstein College of Medicine 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 10 inclusion and 4 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 26 May 2021. 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 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 29 Jan 2020). 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?
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027754, which also lists 2 linked publications.
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 26 May 2021.