Project Q Pilot: Smoking Cessation for Light Smokers

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Cognitive behavioral cessation counseling	Cognitive behavioral cessation counseling	Standard smoking cessation plus support text messages
Placebo Comparator: Counseling and placebo drug intervention	Cognitive behavioral cessation counseling	enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Placebo Comparator: Counseling and placebo drug intervention	Counseling and placebo drug intervention	enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Active Comparator: Counseling and active drug intervention	Cognitive behavioral cessation counseling	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.
Active Comparator: Counseling and active drug intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Validated Cessation	1 week post-intervention	Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.

Project Q Pilot: Smoking Cessation for Light Smokers

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

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