Cigarette Smoking | Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients
Cigarette Smoking research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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 30 days and be stable on the current methadone dose for at least 1 week 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 Quitbit cigarette lighter assessments, with at least 5 days of useable data, smoke ≥ 10 cigarettes/day and smoke at least 30% 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 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 5. have had clinically significant cardiovascular or cerebrovascular disease within the past 6 months or have clinically significant ECG abnormalities 6. have taken an investigational drug within 30 days before consent 7. be taking concomitant medications that are contraindicated for use with the NNS or varenicline 8. be taking any concomitant medications that could increase the likelihood of smoking cessation (such as wellbutrin or nortriptyline) 9. have a known or suspected hypersensitivity to varenicline or the NNS 10. use/have used smoking-cessation counseling programs with individual counseling or smoking-cessation medication treatments currently, or within 30 days before consent 11. have used electronic cigarettes or tobacco products, other than cigarettes, in the week before consent 12. be pregnant or breastfeeding 13. 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.)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Nicotine Nasal Spray7 days. 1 mg/dose, up to 40x/day.
Drug:Varenicline14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
Drug:Placebo Nasal Spray7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
Drug:Placebo Varenicline14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Order 1Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).
Order 2Subjects assigned to this arm will receive Placebo Nasal Spray first (Week 1), followed by Nicotine Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).
Order 3Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Placebo Varenicline (Weeks 6-7).
Order 4Subjects assigned to this arm will receive Nicotine Nasal Spray first (Week 1), followed by Placebo Nasal Spray (Week 2), followed by Placebo Varenicline (Weeks 3-4), followed by a washout period (Week 5) and then Varenicline (Weeks 6-7).
Start Date: March 2016
Completed Date: August 25, 2017
Phase: Phase 4
Primary Outcome: Proportion of daily cigarettes smoked in the 4 hours after receiving methadone dose
Secondary Outcome: Cigarettes per day
Study sponsors, principal investigator, and references
Principal Investigator: Theresa Winhusen, PhD
Lead Sponsor: University of Cincinnati