Smoking Clinical Trial
Official title:
UW-CTRI Smoking Cessation Medication Tolerability Study
Verified date | September 2017 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 13, 2016 |
Est. primary completion date | June 13, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Age >17 years; - >=5 cigarettes/day for the previous 6 months; - alveolar CO >= 6 ppm; able to read, write and speak English; - planning to remain in the intervention catchment area for at least 4 months; not currently taking bupropion or varenicline; - if the participant is currently using NRT, s/he agrees to use only study medication for the duration of the study; - free of medical contraindications to NRT and varenicline; and, - if participant is a woman of childbearing potential, using an approved method of birth control during treatment. Exclusion Criteria: - Current diagnosis of/treatment for psychosis or bipolar disorder; - suicidal ideation within the past 12 months; any history of suicide attempts; * significant hepatic or renal impairment; history of significant allergic reactions to varenicline or any type of NRT in the past; - use of any investigational drugs in the previous 30 days. - |
Country | Name | City | State |
---|---|---|---|
United States | UW CTRI | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Events | Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period | 12 weeks | |
Secondary | Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms | Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction) | Week 12 | |
Secondary | Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking | Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction) | Week 12 | |
Secondary | Number of Participants Who Reported Quitting at the End of Treatment | Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call | Week 12 |
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