Project Q Pilot: Smoking Cessation for Light Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Project Q Pilot: Examining Different Treatment Modalities to Maximize Cessation Efforts for Light Smokers

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Cognitive behavioral cessation counseling
* Behavioral: Counseling and placebo drug intervention
* Drug: Counseling and active drug intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: Cognitive behavioral cessation counseling<br>Standard smoking cessation plus support text messages | Behavioral: Cognitive behavioral cessation counseling<br>* Standard smoking cessation plus support text messages<br>|
| Placebo Comparator: Placebo Comparator: Counseling and placebo drug intervention<br>enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo | Behavioral: Cognitive behavioral cessation counseling<br>* Standard smoking cessation plus support text messages<br>Behavioral: Counseling and placebo drug intervention<br>* Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo<br>|
| Experimental: Active Comparator: Counseling and active drug intervention<br>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. | Behavioral: Cognitive behavioral cessation counseling<br>* Standard smoking cessation plus support text messages<br>Drug: Counseling and active drug intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Completion of at Least 2 Study Visits | Feasibility will be determined by number of participants that complete at least 2 study visits. | Approximately 8 weeks | 
| Number of Participants Who Rated the Intervention Acceptable | 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. | Approximately 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Validated Cessation | Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention. | 1 week post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Light Smoker