Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-02 @ 8:04 PM
Study NCT ID:
NCT02147132
Status:
TERMINATED
Last Update Posted:
2018-12-05
First Post:
2014-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients
Sponsor:
University of Cincinnati
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting eligible participants; study medication was expiring.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: