NCT02147132

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-08-25
• Completion: 2017-08-25
• First posted: 2014-05-26
• Last updated: 2018-12-05
• Results posted: 2018-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study