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

NCT02147132 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2013-7275
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking; Methadone Maintenance

Keywords

Cigarette; Methadone; Smoking; Cessation; Varenicline; Nicotine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cigarettes Per Day

  7 weeks

• Number of Participants With Carbon Monoxide Levels Less Than or Equal to 8 Parts-per-million

  up to 8 weeks

Study Arms (4)

Order 1

EXPERIMENTAL

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).

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

Order 2

EXPERIMENTAL

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).

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

Order 3

EXPERIMENTAL

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).

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

Order 4

EXPERIMENTAL

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).

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

Interventions

Nicotine Nasal Spray DRUG

7 days. 1 mg/dose, up to 40x/day.

Order 1; Order 2; Order 3; Order 4

Varenicline DRUG

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.

Order 1; Order 2; Order 3; Order 4

Placebo Nasal Spray DRUG

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.

Order 1; Order 2; Order 3; Order 4

Placebo Varenicline DRUG

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.

Order 1; Order 2; Order 3; Order 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be male or female, 18 years of age or older
• be able to understand the study, and having understood, provide written informed consent in English
• 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
• 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
• have a willingness to comply with all study procedures, including trying to stop smoking during designated weeks, and to comply with medication instructions
• 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
• 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.

You may not qualify if:

• have a current or past diagnosis of any psychotic disorder, or bipolar I or II disorder
• have a psychiatric condition that, in the judgment of the study physician would make study participation unsafe or which would make treatment compliance difficult
• be a significant suicidal/homicidal risk
• 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
• have had clinically significant cardiovascular or cerebrovascular disease within the past 6 months or have clinically significant ECG abnormalities
• have taken an investigational drug within 30 days before consent
• be taking concomitant medications that are contraindicated for use with the NNS or varenicline
• be taking any concomitant medications that could increase the likelihood of smoking cessation (such as wellbutrin or nortriptyline)
• have a known or suspected hypersensitivity to varenicline or the nicotine nasal spray (NNS)
• use/have used smoking-cessation counseling programs with individual counseling or smoking-cessation medication treatments currently, or within 30 days before consent
• have used electronic cigarettes or tobacco products, other than cigarettes, in the week before consent
• be pregnant or breastfeeding
• 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.)

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

UC Physicians Company, LLC Opioid Treatment Program

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Interventions

Tobacco Use Cessation Devices; Varenicline

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Jeff Theobald
• Organization: UC COM Psychiatry Dept. -- Addiction Sciences Division

theobajy@ucmail.uc.edu

5135858281

Study Officials

• Theresa Winhusen, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 26, 2014
• Study Start: March 1, 2016
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-12

Locations

US (1)