Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Cigarette Smoking, Methadone Maintenance

In brief

The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.

Key facts

Study ID

NCT02147132

Run by

University of Cincinnati

People needed

7

Starts

2016-03-01

Expected to finish

2017-08-25

Last updated by the study team

2018-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• be male or female, 18 years of age or older
• be able to understand the study, and having understood, provide written informed consent in English
• have been enrolled in the University of Cincinnati Physicians Company-Opioid Treatment Program (UCPC-OTP) program for at least 30 days and be stable on the current methadone dose for at least 1 week
• have smoked cigarettes for at least 3 months, have a measured exhaled carbon monoxide (CO) level > 8 parts per million (ppm), and not planning to seek smoking-cessation treatment within the next 3 months
• have a willingness to comply with all study procedures, including trying to stop smoking during designated weeks, and to comply with medication instructions
• based on a week of Quitbit cigarette lighter assessments, with at least 5 days of usable data, smoke ≥ 10 cigarettes/day and smoke at least 30% of daily cigarettes within the 4-hour post-methadone-dosing period
• if female and of child bearing potential, agree to use one of the following methods of birth control: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), intrauterine contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection,complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring.

You may not qualify if…

• have a current or past diagnosis of any psychotic disorder, or bipolar I or II disorder
• have a psychiatric condition that, in the judgment of the study physician would make study participation unsafe or which would make treatment compliance difficult
• be a significant suicidal/homicidal risk
• have a medical condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Such conditions include, but are not limited to:
• liver function tests greater than 3 times upper limit of normal
• serum creatinine greater than 2 mg/dL
• have had clinically significant cardiovascular or cerebrovascular disease within the past 6 months or have clinically significant ECG abnormalities
• have taken an investigational drug within 30 days before consent
• be taking concomitant medications that are contraindicated for use with the NNS or varenicline
• be taking any concomitant medications that could increase the likelihood of smoking cessation (such as wellbutrin or nortriptyline)
• have a known or suspected hypersensitivity to varenicline or the nicotine nasal spray (NNS)
• use/have used smoking-cessation counseling programs with individual counseling or smoking-cessation medication treatments currently, or within 30 days before consent
• have used electronic cigarettes or tobacco products, other than cigarettes, in the week before consent
• be pregnant or breastfeeding
• be anyone who, in the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)

Where it is running

• UC Physicians Company, LLC Opioid Treatment Program — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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