- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202499
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Following the initial telephone screening, eligible participants will be scheduled for a screening evaluation session.
Following the screening evaluation, participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus facilitated extinction (EV + FE). The randomization list will be generated by the study statistician. It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥18 years of age
- Smoke at least 10 cigarettes daily for the past year
- Expired-air carbon monoxide (CO) > 8 ppm
- Medically eligible to receive varenicline
- Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking.
Exclusion Criteria:
- Are pregnant or lactating
- Have renal dysfunction
- Have a history of seizures
- Are medically at risk in the judgment of the study physician
- Have ever used varenicline
- Have used other smoking cessation medications within the past three months
- Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders)
- Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI]; Sheehan et al 2015).
- We must limit the number of participants from the same street address to 1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Extended Varenicline + Facilitated Extinction
Extended Varenicline plus Facilitated Extinction (EV+FE).
Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke.
In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.
All groups will undergo periodic laboratory assessments and surveys.
|
All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study.
Arm descriptions show specific details for each group.
Other Names:
Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.
The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test.
The second laboratory assessment will be scheduled for the end of the week before the participant's quit date.
It will involve completion of questionnaires and another cue reactivity test.
A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment.
A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use.
At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.
|
Active Comparator: Standard Varenicline (SV)
Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke.
All groups will undergo periodic laboratory assessments and surveys.
|
All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study.
Arm descriptions show specific details for each group.
Other Names:
The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test.
The second laboratory assessment will be scheduled for the end of the week before the participant's quit date.
It will involve completion of questionnaires and another cue reactivity test.
A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment.
A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use.
At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.
|
Active Comparator: Extended Varenicline (EV)
Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke.
All groups will undergo periodic laboratory assessments and surveys.
|
All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study.
Arm descriptions show specific details for each group.
Other Names:
The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test.
The second laboratory assessment will be scheduled for the end of the week before the participant's quit date.
It will involve completion of questionnaires and another cue reactivity test.
A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment.
A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use.
At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Participant Retention
Time Frame: End of post treatment follow-up period of 3 months - approximately 28 weeks
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Practicality: Number of participants completing 3 month post treatment follow-up.
Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).
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End of post treatment follow-up period of 3 months - approximately 28 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Client Satisfaction Questionnaire (CSQ) Results
Time Frame: One month post treatment - approximately 20 weeks
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Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield.
Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied.
Score total range is 8-32.
A total score of 32 would be the highest possible Client Satisfaction Score.
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One month post treatment - approximately 20 weeks
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Rate of Intervention Adherence - Medication
Time Frame: One month post treatment - approximately 20 weeks
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Percent of participants still using varenicline at time of analysis.
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One month post treatment - approximately 20 weeks
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Average Intervention Adherence - Cigarettes Per Day (CPD)
Time Frame: During last week of treatment, week 16
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Average Cigarettes per Day across group, during last week of treatment.
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During last week of treatment, week 16
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Mean Peak Craving Score Per Group
Time Frame: Across 4 pre-quit weeks
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Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10.
0 was "none", 5 "medium" and 10 "very high/strong"
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Across 4 pre-quit weeks
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Mean Smoking Satisfaction Score Per Group
Time Frame: Across 4 pre-quit weeks
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Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10.
0 was "none", 5 "medium" and 10 "very high"
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Across 4 pre-quit weeks
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-17654
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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