Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

NCT00790569 | Completed Results DMC

• 3 other identifiers: CDR0000616663R01CA129226BUTLER-0807-004
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking. PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.

Conditions

Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder

Keywords

bladder cancer; cervical cancer; esophageal cancer; gastric cancer; renal cell carcinoma; adult primary liver cancer; non-small cell lung cancer; small cell lung cancer; pancreatic cancer; hypopharyngeal cancer; laryngeal cancer; lip and oral cavity cancer; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; adult acute myeloid leukemia; tobacco use disorder

Outcome Measures

Primary Outcomes (5)

• Self- Reported 7-day Abstinence

  Number of participants with self-reported, 7-day abstinence at 6-months

  6 Months

• Carbon Monoxide (CO)-Confirmed 7-day Abstinence

  Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.

  6-Months

• Rates of Smoking Cessation Continuous From First Quit Day to 6 Months

  Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months

  6-Months

• Self-reported 7-day Abstinence

  Number of participants with self-reported 7-day abstinence at 12-months

  12 Months

• CO-confirmed 7-day Abstinence

  Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.

  12 Months

Secondary Outcomes (7)

• Change in Smoking Urges

  6 months

• Withdrawal Symptoms

  6 months

• Retention in Methadone Maintenance

  12 months

• Methadone Dose Changes

  12 months

• Use of Illicit Drugs as Measured by Urine Toxicologies

  12 months

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.

Drug: varenicline

Arm II

PLACEBO COMPARATOR

Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.

Other: placebo

Arm III

ACTIVE COMPARATOR

Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.

Drug: nicotine

Interventions

nicotine DRUG

Given transdermally and orally

Arm III

varenicline DRUG

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
• Interested in quitting smoking
• Willing to set a quit date 7 days after baseline assessment
• Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:
• Codac, Inc. (with two independent sites)
• Addiction Recovery Institute
• Center for Treatment and Recovery
• Discovery House
• Has received methadone for at least the past month

You may not qualify if:

• Pregnant or nursing (Must have negative pregnancy test)
• Non-English speaking
• No personal telephone or does not live close to a relative or neighbor with a telephone
• Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
• Unvailable for this study for the next 12 months
• Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
• Active skin condition (e.g., psoriasis)
• History of skin allergy
• History of a suicide attempt
• Working as pilots, drivers, or operators of heavy machinery
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No concurrent insulin or blood thinners
• No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment

Sponsors & Collaborators

• Butler Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

• Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug Alcohol Depend. 2013 Dec 1;133(2):486-93. doi: 10.1016/j.drugalcdep.2013.07.005. Epub 2013 Aug 14.

  PMID: 23953658 BACKGROUND

• 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

• de Dios MA, Anderson BJ, Caviness CM, Stein M. Intimate partner violence among individuals in methadone maintenance treatment. Subst Abus. 2014;35(2):190-3. doi: 10.1080/08897077.2013.835764.

  PMID: 24821357 DERIVED

• Caviness CM, Bird JL, Anderson BJ, Abrantes AM, Stein MD. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. J Subst Abuse Treat. 2013 Apr;44(4):457-62. doi: 10.1016/j.jsat.2012.10.002. Epub 2012 Nov 28.

  PMID: 23199641 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Head and Neck Neoplasms; Kidney Neoplasms; Leukemia; Liver Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Tobacco Use Disorder; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms; Leukemia, Myeloid, Acute

Interventions

Nicotine; Varenicline

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Kidney Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Mouth Diseases; Nasopharyngeal Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines

Results Point of Contact

• Title: Dr. Michael Stein
• Organization: Butler Hospital

michael_stein@brown.ed

401-455-6646

Study Officials

• Michael Stein, MD

  Butler Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 6, 2018
• Results First Posted: February 3, 2014

Record last verified: 2018-05

Locations

US (1)