Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking - Full Text View

Sponsored by:	Butler Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00790569

Purpose

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.

Condition	Intervention
Bladder Cancer Cancer-Related Problem/Condition Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer	Drug: nicotine Drug: placebo Drug: varenicline

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Liver Cancer Lung Cancer Pancreatic Cancer Smoking Stomach Cancer

Drug Information available for: Methadone Methadone hydrochloride Varenicline Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized
Official Title:	Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Rates of smoking cessation [ Designated as safety issue: No ]

Secondary Outcome Measures:

Smoking urges [ Designated as safety issue: No ]
Withdrawal symptoms [ Designated as safety issue: No ]
Reinforcing effects of smoking [ Designated as safety issue: No ]
Retention in methadone maintenance [ Designated as safety issue: No ]
Methadone dose changes [ Designated as safety issue: No ]
Use of illicit drugs as measured by urine toxicologies [ Designated as safety issue: No ]

Estimated Enrollment:	602
Study Start Date:	September 2008
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Given orally
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.	Drug: placebo Given orally
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 Given transdermally and orally

Detailed Description:

OBJECTIVES:

Primary

To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers.

Secondary

To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking.
To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies.

OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms.

At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number.

Arm I (varenicline): 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.
Arm II (placebo): 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.
Arm III (nicotine patch/gum): 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.

Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing).

NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer.

PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Negative pregnancy test
English speaking
Has a telephone or lives close to a relative or neighbor with a telephone
Willing to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
Available for this study for the next 12 months
Not suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
No active skin condition (e.g., psoriasis)
No history of skin allergy
No history of a suicide attempt
Not 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790569

Locations

United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488

Sponsors and Collaborators

Butler Hospital

Investigators

Study Chair:

Michael Stein, MD

Butler Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Rhode Island Hospital Comprehensive Cancer Center ( Michael Stein )
Study ID Numbers:	CDR0000616663, BUTLER-0807-004
Study First Received:	November 11, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00790569
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Nicotine polacrilex
Thoracic Neoplasms
Liver Diseases
Pancreatic Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Smoking
Lung Neoplasms
Oral cancer
Laryngeal carcinoma
Acute myeloid leukemia, adult
Kidney Diseases
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms

Tobacco Use Disorder
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Acute myelogenous leukemia
Endocrine System Diseases
Stomach cancer
Renal cancer
Leukemia, Myeloid
Lip and oral cavity cancer
Carcinoma
Carcinoma, Small Cell
Lung Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Esophageal Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neurotransmitter Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009