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Completed

NCT Number: NCT03416621

Project Q Pilot: Smoking Cessation 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duke University Medical Center - Cancer Prevention, Detection and Control

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral cessation counseling

Behavioral

Standard smoking cessation plus support text messages

Counseling and placebo drug intervention

Behavioral

Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo

Counseling and active drug intervention

Drug

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 outcomes

  1. Number of Participants With Completion of at Least 2 Study Visits

    Time frame: Approximately 8 weeks

    Feasibility will be determined by number of participants that complete at least 2 study visits.

  2. Number of Participants Who Rated the Intervention Acceptable

    Time frame: 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 outcomes

  1. Number of Participants With Validated Cessation

    Time frame: 1 week post-intervention

    Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2018
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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