Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
Public ClinicalTrials.gov record NCT01296698. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week Trial to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers in a Naturalistic Environment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home. Approximately 1500 subjects will be enrolled into the study. The study will require participants to use the treatment for 12 weeks and there will be a 14-week follow-up period. The study will be conducted in approximately 20 pharmacies across the United States. At the first visit to the pharmacy, participants will be asked some questions to see if they are eligible to participate. Participants will be asked to sign a consent form if they agree to participate. Participants will answer some more questions, and blow into a machine to measure their carbon monoxide (CO) levels to make sure they qualify for the trial. Participants will be asked to go to a nearby dentist who will look at their mouths. Participants will go back to the pharmacy and if they qualify, they will be given a supply of their assigned treatment. They will have an equal chance of receiving a treatment that has a drug in it or one that has no drug in it. They will be given a diary to keep track of how much of the treatment they use. Subjects will go to the pharmacy four more times to hand in their diaries and blow into a machine that will measure their CO levels. At the last visit, subjects will have their mouths examined by a dentist again to have their mouth checked. Subjects will receive four telephone calls during the study where they will be asked some questions. After the 12 week treatment period, subjects will receive two to three more telephone calls, where they will be asked to answer some questions. Participants may be asked to come back to the pharmacy two more times to blow into the carbon monoxide machine again.
Study identification
- NCT ID
- NCT01296698
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 257 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2011 (Type not available)
- Primary completion
- Apr 2011 (Actual)
- Completion
- Jun 2011 (Actual)
- Last update posted
- Apr 23, 2012
2011
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Avalon Discount Drugs | Muscle Shoals | Alabama | 35661 | — |
| Coast Compounding Pharmacy | Oceanside | California | 92054 | — |
| Wynn's Pharmacy, Inc. | Griffin | Georgia | 30224 | — |
| Stark Pharmacy | Overland Park | Kansas | 64116 | — |
| Goodrich Pharmacy | Anoka | Minnesota | 55303 | — |
| Goodrich Pharmacy | Elk River | Minnesota | 55330 | — |
| Goodrich Pharmacy | Saint Francis | Minnesota | 55070 | — |
| Cub Pharmacy #1924 | Saint Louis Park | Minnesota | 55426 | — |
| Medicap Pharmacy | Clarksdale | Mississippi | 38614 | — |
| Liddy's Health Mart | Holly Springs | Mississippi | 38635 | — |
| Countryside Pharmacy | Savannah | Missouri | 64485 | — |
| Phil's Pills | Albuquerque | New Mexico | 87110 | — |
| Kerr Drug | Raleigh | North Carolina | 27609 | — |
| Family Prescription Center | Bethlehem | Pennsylvania | 18015 | — |
| T.B. Bond Pharmacy | Hillsboro | Texas | 76645 | — |
| Inwood Pharmacy | Houston | Texas | 77070 | — |
| Louis Morgan Drug #1 | Longview | Texas | 75602 | — |
| Brick Street Pharmacy | Tyler | Texas | 75701 | — |
| Montpelier Pharmacy, Inc. | Montpelier | Virginia | 23192 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01296698, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2012 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01296698 live on ClinicalTrials.gov.