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

NCT02147132 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-12-05

Study results available
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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

Interventions

DRUG

Nicotine Nasal Spray

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

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Theresa Winhusen, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-08-25
Completion
2017-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147132 on ClinicalTrials.gov