Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients
Condition: Cigarette Smoking; Methadone Maintenance
Intervention: Nicotine Nasal Spray; Varenicline; Placebo Nasal Spray; Placebo Varenicline
Intervention description: 7 days. 1 mg/dose, up to 40x/day.; 14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.; 7 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.; 14 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.
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cigarette; Methadone; Smoking; Cessation; Varenicline; Nicotine

Summary:

      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.
    

Eligibility 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 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

          4. 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

          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
             usable 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 3 times 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 nicotine nasal spray
             (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.)