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

Condition(s) targeted: Cigarette Smoking; Methadone Maintenance

Intervention: Nicotine Nasal Spray (Drug); Varenicline (Drug); Placebo Nasal Spray (Drug); Placebo Varenicline (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Theresa Winhusen, PhD, Principal Investigator, Affiliation: University of Cincinnati

Overall contact:
Jeffrey Theobald, Phone: 513-585-8281, Email: theobajy@ucmail.uc.edu

Smoking prevalence is over 83% in methadone-maintained patients. These patients experience significant difficulty quitting, and there is evidence that a majority of methadone-maintained patients smoke most of their cigarettes in the 4 hours following methadone dosing. 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.

Official title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Proportion of daily cigarettes smoked in the 4 hours after receiving methadone dose

Secondary outcome:

Cigarettes per day

Carbon monoxide level

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. be male or female, 18 years of age or older 2. be able to understand the study, and having understood, provide written informed consent in English 3. have been enrolled in the UCPC-OTP program for at least 3 months and be stable on the current methadone dose for at least a month 4. have smoked cigarettes for at least 3 months, have a measured exhaled CO level > 8 ppm, and not planning to seek smoking-cessation treatment within the next 3 months 5. have a willingness to comply with all study procedures, including trying to stop smoking during designated weeks, and to comply with medication instructions 6. based on a week of SmokeSignals® cigarette pack assessments, smoke > 10 cigarettes/day and smoke at least 40% of daily cigarettes within the 4 hour post-methadone-dosing period 7. 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. Exclusion Criteria: 1. have a current or past diagnosis of any psychotic disorder, or bipolar I or II disorder 2. have a psychiatric condition that, in the judgment of the study physician would make study participation unsafe or which would make treatment compliance difficult 3. be a significant suicidal/homicidal risk 4. have a positive urine drug screen for anything other than opioids 5. 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 3X upper limit of normal

- serum creatinine greater than 2 mg/dL

6. have had clinically significant cardiovascular or cerebrovascular disease within the past 6 months or have clinically significant ECG abnormalities 7. have taken an investigational drug within 30 days before consent 8. be taking concomitant medications that are contraindicated for use with the NNS or varenicline 9. be taking any concomitant medications that could increase the likelihood of smoking cessation (such as wellbutrin or nortriptyline) 10. have a known or suspected hypersensitivity to varenicline or the NNS 11. use/have used smoking-cessation counseling programs or medication treatments currently, or within 30 days before consent 12. have used electronic cigarettes or tobacco products, other than cigarettes, in the week before consent 13. be pregnant or breastfeeding 14. 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.)

Jeffrey Theobald, Phone: 513-585-8281, Email: theobajy@ucmail.uc.edu

UC Physicians Company, LLC Opioid Treatment Program, Cincinnati, Ohio 45229, United States; Active, not recruiting

Starting date: December 2014
Last updated: December 5, 2014