- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416621
Project Q Pilot: Smoking Cessation for Light Smokers
March 4, 2021 updated by: Duke University
Project Q Pilot: Examining Different Treatment Modalities to Maximize Cessation Efforts for Light Smokers
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
Study Overview
Status
Completed
Conditions
Detailed Description
The three-arm randomized controlled trial compares Arm 1) standard smoking cessation plus support text messages, 2) enhanced cue exposure treatment (lab-based + interactive SMS texting) + D-cycloserine placebo, Arm 3)will include a combination of cognitive behavioral cessation counseling, enhanced cue exposure treatment (lab-based + interactive SMS texting) and a cognitive-enhancing drug - D-cycloserine.
In addition to an in-person screening visit, we will conduct three in-person treatment visits and an inperson follow-up visit.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center - Cancer Prevention, Detection and Control
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: ≥18 years old
- Able to read and understand English or Spanish
- Cognitively able to provide informed consent
- Smoke 1-10 cigs/day on at least 4 days in the past month
- Express a desire to quit smoking in the next 30 days
- Access to a cell phone that can send and receive SMS text messages and take and send pictures
Exclusion Criteria:
- Hypertension with a screening blood pressure over 160/100;
- Hypotension with a screening blood pressure of systolic <90 mm Hg, diastolic <60 mm Hg;
- Participants with a history of hypertension may be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;
- Coronary heart disease, diagnosed by coronary angiogram;
- History of major heart attack;
- Major cardiac rhythm disorder determined by study MD;
- Chest pain in the last month (unless history, exam, indicate a non-cardiac source);
- Symptomatic cardiac disorder (valvular heart disease, heart murmur, heart failure);
- Diagnosis of severe liver disease or kidney disorder;
- Major gastrointestinal problems or disease (Celiac, Crohn's, Ulcerative Colitis)
- Bleeding ulcers in the past 30 days;
- Current, advanced lung disorder/disease (COPD, emphysema);
- Migraine headaches that occur more frequently than once per week;
- Recent, unexplained fainting spells;
- Problems giving blood samples;
- Diabetes not controlled by diet and exercise alone;
- Current cancer or cancer treatment in the past six months (except basal or squamous cell skin cancer);
- HIV, Hepatitis B, or Hepatitis C;
- History of Tuberculosis or recent positive PPD;
- Other major medical condition;
- Current symptomatic, uncontrolled psychiatric disease;
- Diagnosis of serious mental illness, including bipolar disorder and schizophrenia;
- Suicidal ideation within the past month or lifetime occurrence of attempted suicide;
- Current (within 2 weeks) depression determined by PHQ-9 score > 9 or > 0 on item #9
- Bulimia or anorexia;
- Pregnant or nursing;
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive for Cocaine, Amphetamine, Opiates, Methamphetamines, PCP, Benzodiazepines, or Barbiturates), unless prescribed for management of acute symptoms (tooth extraction, recent surgery);
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants (MAOIs, St. John's Wort), lithium, anti-psychotics, or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid.
- Use of cigars, cigarillos, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco , or e-cigarettes within the past 30 days;
- Positive result on AUDIT-C;
- Self-report of marijuana use ≥ 4 days per week;
- Significant adverse reaction to D-cycloserine in the past;
- Current or recent (in the past 30 days) participation in another smoking study at our Center or another research facility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Experimental: Cognitive behavioral cessation counseling
Standard smoking cessation plus support text messages
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Standard smoking cessation plus support text messages
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Placebo Comparator: Placebo Comparator: Counseling and placebo drug intervention
enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
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Standard smoking cessation plus support text messages
Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
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Experimental: Active Comparator: Counseling and active drug intervention
enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS.
In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
|
Standard smoking cessation plus support text messages
Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS.
In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Completion of at Least 2 Study Visits
Time Frame: Approximately 8 weeks
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Feasibility will be determined by number of participants that complete at least 2 study visits.
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Approximately 8 weeks
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Number of Participants Who Rated the Intervention Acceptable
Time Frame: Approximately 8 weeks
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Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful.
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Approximately 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Validated Cessation
Time Frame: 1 week post-intervention
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Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.
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1 week post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2018
Primary Completion (Actual)
February 29, 2020
Study Completion (Actual)
February 29, 2020
Study Registration Dates
First Submitted
January 24, 2018
First Submitted That Met QC Criteria
January 24, 2018
First Posted (Actual)
January 31, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2021
Last Update Submitted That Met QC Criteria
March 4, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00089760
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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