Smoking Cessation Treatment for Methadone Maintenance Patients

Smoking Cessation Clinical Trial

Official title:

Smoking Cessation Treatment for Methadone Maintenance Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027754
• Other study ID #: 2008-537
• Secondary ID: UL1RR025750
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: May 2021
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Smoking Cessation
• Substance-Related Disorders

Intervention

Drug:
• Varenicline
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
• Placebo
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine of Yeshiva University	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.		Week 12
Secondary	Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.		Week 24
Secondary	Number of Counseling Visits Completed	Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.	End of 12 week intervention period
Secondary	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.	24 weeks
Secondary	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™).	Weeks 2, 4, 8, 12, and 24
Secondary	Number of Cigarettes Smoked Per Day		Weeks 2, 4, 8, 12, and 24
Secondary	Number of Participants With an Attempt to Quit Smoking That Lasted = 24 Hours		Weeks 2, 4, 8, 12, and 24
Secondary	Confidence in Quitting Smoking (1-10 Scale)	Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).	Weeks 2, 4, 8, 12, and 24
Secondary	Importance of Quitting Smoking (1-10 Scale)	Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).	Weeks 2, 4, 8, 12, and 24
Secondary	Adverse Medication Effects		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Secondary	Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Secondary	Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Secondary	Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Secondary	Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Secondary	Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview		over the intervention period (measured at weeks 2, 4, 8, 12, and 24)