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

Cigarette Smoking Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02147132
• Other study ID #: 2013-7275
• Status: Terminated
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: August 25, 2017

Study information

• Verified date: December 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 25, 2017
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Cigarette Smoking
• Methadone Maintenance

Intervention

Drug:
• Nicotine Nasal Spray
7 days. 1 mg/dose, up to 40x/day.
• Varenicline
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.
• Placebo Nasal Spray
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.
• Placebo Varenicline
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.

Locations

Country	Name	City	State
United States	UC Physicians Company, LLC Opioid Treatment Program	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose	Subjects will be given a special electronic cigarette lighter called Quitbit.The electronic lighter will record a timestamp for each time the lighter is used to light a cigarette. Data will be collected from the lighter at each study visit. This will measure how many cigarettes are smoked and when.	7 weeks
Secondary	Cigarettes Per Day	The Quitbit lighter will measure how many cigarettes are smoked per day. In addition to the Quitbit lighter measurement, the Timeline Follow Back (TLFB) form will be filled out for each subject to measure use, as well.	7 weeks
Secondary	Number of Participants With Carbon Monoxide Levels Less Than or Equal to 8 Parts-per-million	Carbon monoxide (CO) in each participant's breath will be tested. A CO level less than or equal to 8 parts-per-million will be used to verify reports of no smoking.	up to 8 weeks