Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

NCT01378858 | Completed Results DMC

• 2 other identifiers: 2010-279K23DA025736
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.

Conditions

Tobacco Use Disorder; Medication Adherence

Keywords

Smoking; Substance-Related Disorders; medication adherence; Methadone

Outcome Measures

Primary Outcomes (1)

• Varenicline Adherence as Measured by Pill Count

  Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure

  Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12

Secondary Outcomes (2)

• Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks

  Week 12 of treatment

• Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks

  24 weeks

Study Arms (2)

Varenicline treatment as usual (TAU)

EXPERIMENTAL

Subjects in the TAU arm will self administer varenicline for 12 weeks.

Drug: Varenicline

Varenicline directly observed therapy

EXPERIMENTAL

Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.

Drug: Varenicline

Interventions

Varenicline DRUG

Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.

Also known as: Chantix

Varenicline directly observed therapy; Varenicline treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• English speaking
• Smoked at least 100 cigarettes/lifetime
• Smoke 5 or more cigarettes per day
• Interested in quitting smoking (preparation or contemplation stage of change)
• Enrolled in Einstein/Montefiore methadone program for 12 weeks or more
• Receiving methadone in clinic three, four, five or six times per week
• No more than 2 methadone clinic misses in prior 14 days
• Agree to use contraception for the duration of the trial (among women with reproductive potential)
• Willing to participate in all study components
• Able to provide informed consent

You may not qualify if:

• Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
• Psychiatric instability
• Women who are pregnant, breastfeeding, or contemplating pregnancy
• Creatinine clearance \<30 mL/min

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (3)

• 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.

  PMID: 37142273 DERIVED

• Nahvi S, Adams TR, Ning Y, Zhang C, Arnsten JH. Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial. Addiction. 2021 Apr;116(4):902-913. doi: 10.1111/add.15240. Epub 2020 Oct 13.

  PMID: 32857445 DERIVED

• Nahvi S, Segal KS, Litwin AH, Arnsten JH. Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics. Addict Sci Clin Pract. 2014 Jun 13;9(1):9. doi: 10.1186/1940-0640-9-9.

  PMID: 24928218 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Medication Adherence; Smoking; Substance-Related Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Shadi Nahvi, MD, MS
• Organization: Albert Einstein College of Medicine

snahvi@montefiore.org

718 920 5379

Study Officials

• Shadi Nahvi, M.D., M.S.

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-03

Locations

US (1)