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

University of Cincinnati

Status and phase: Terminated; Phase 4

Conditions: Cigarette Smoking; Methadone Maintenance

Treatments: Drug: Placebo Varenicline; Drug: Placebo Nasal Spray; Drug: Varenicline; Drug: Nicotine Nasal Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT02147132

2013-7275

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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7 participants in 4 patient groups

Order 1

Experimental group

Description:

Subjects 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).

Treatment:

Drug: Varenicline

Drug: Nicotine Nasal Spray

Drug: Placebo Nasal Spray

Drug: Placebo Varenicline

Order 2

Experimental group

Description:

Subjects 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).

Treatment:

Drug: Varenicline

Drug: Nicotine Nasal Spray

Drug: Placebo Nasal Spray

Drug: Placebo Varenicline

Order 3

Experimental group

Description:

Subjects 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).

Treatment:

Drug: Varenicline

Drug: Nicotine Nasal Spray

Drug: Placebo Nasal Spray

Drug: Placebo Varenicline

Order 4

Experimental group

Description:

Subjects 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).

Treatment:

Drug: Varenicline

Drug: Nicotine Nasal Spray

Drug: Placebo Nasal Spray

Drug: Placebo Varenicline