Cigarette SmokingPhase 4NCT02147132

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

A Phase 4 study testing Nicotine Nasal Spray and Varenicline in people with Cigarette Smoking and Methadone Maintenance, run by University of Cincinnati at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cigarette Smoking, Methadone Maintenance
What is being tested?: Nicotine Nasal Spray and Varenicline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Mar 2016to 25 Aug 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 15Show fewer

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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Physicians Company, LLC Opioid Treatment Program
Cincinnati, Ohio, 45229

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Cigarette Smoking, Methadone Maintenance
Being tested: Nicotine Nasal Spray, Varenicline, Placebo Nasal Spray, Placebo Varenicline
Keywords: Cigarette, Methadone, Smoking, Cessation, Varenicline, Nicotine
Medical subject headings: Cigarette Smoking, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nicotine Nasal SprayDrug
7 days. 1 mg/dose, up to 40x/day.
VareniclineDrug
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 SprayDrug
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 VareniclineDrug
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.

Study groups in NCT02147132
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Nicotine Nasal Spray; Drug: Varenicline; Drug: Placebo Nasal Spray; Drug: Placebo Varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 weeks

Secondary outcomes (2)

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.
Measured: 7 weeks
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.
Measured: up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201625 Aug 2017

First posted26 May 2014 (estimated)
Study startMar 2016
Primary completion25 Aug 2017
Study completion25 Aug 2017

Why it stopped: Difficulty recruiting eligible participants; study medication was expiring.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cigarette SmokingStudies of the same condition, open and under way.
More trials run by University of CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02147132
Sponsor's protocol ID: 2013-7275
Status last verified: Dec 2018
First submitted: 19 May 2014
Last updated: 5 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 37142273

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02147132
Acronym / sponsor ID: 2013-7275
Conditions: Cigarette Smoking, Methadone Maintenance
Keywords: Cigarette, Methadone, Smoking, Cessation, Varenicline, Nicotine
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty recruiting eligible participants; study medication was expiring.
Enrolment: 7 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Study start: Mar 2016
Primary completion: 25 Aug 2017 (actual)
Study completion: 25 Aug 2017 (actual)
First posted: 26 May 2014 (estimated)
Results: Posted 5 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Order 1	Experimental	Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo VareniclineSubjects 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 2	Experimental	Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo VareniclineSubjects 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 3	Experimental	Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo VareniclineSubjects 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 4	Experimental	Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo VareniclineSubjects 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (15 listed)

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:
have had clinically significant cardiovascular or cerebrovascular disease within the past 6 months or have clinically significant ECG abnormalities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nicotine Nasal Spray7 days. 1 mg/dose, up to 40x/day.	Drug	Order 1, Order 2, Order 3, Order 4
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	Order 1, Order 2, Order 3, Order 4
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	Order 1, Order 2, Order 3, Order 4
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.	Drug	Order 1, Order 2, Order 3, Order 4

Primary outcome

Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose
Time frame: 7 weeks
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.

2 secondary outcomes

Cigarettes Per Day
Time frame: 7 weeks
Number of Participants With Carbon Monoxide Levels Less Than or Equal to 8 Parts-per-million
Time frame: up to 8 weeks

Results and safety

Results posted to the registry on 5 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Order 1	2	1
Order 2	2	2
Order 3	1	1
Order 4	2	2

Primary outcome: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose

Time frame: 7 weeks. Mean (Standard Deviation). Unit: proportion of daily cigarettes

Measure	Nicotine Nasal Spray n = 7	Placebo Nasal Spray n = 7	Varenicline Tablets n = 6	Placebo Varenicline Tablets n = 6
Value	0.294 (0.130)	0.177 (0.104)	0.196 (0.088)	0.325 (0.346)

Population analysed: Varenicline and placebo varenicline analysis populations are less than 7 because 1 participant was lost to follow-up and provided no data for these assigned medications.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nicotine Nasal Spray	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Placebo Nasal Spray	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Varenicline Tablets	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Placebo Varenicline Tablets	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37142273Livingstone-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theresa Winhusen, PhD principal investigator

University of Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicotine Nasal Spray and Varenicline in people with Cigarette Smoking and Methadone Maintenance, run by University of Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02147132, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.