Project Q Pilot: Smoking Cessation for Light Smokers

NCT ID: NCT03416621

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-17
• Study Completion Date: 2020-02-29

Brief Summary

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

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.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Cognitive behavioral cessation counseling

Standard smoking cessation plus support text messages

Group Type: ACTIVE_COMPARATOR

Cognitive behavioral cessation counseling

Intervention Type: BEHAVIORAL

Standard smoking cessation plus support text messages

Placebo Comparator: Counseling and placebo drug intervention

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

Group Type: PLACEBO_COMPARATOR

Cognitive behavioral cessation counseling

Intervention Type: BEHAVIORAL

Standard smoking cessation plus support text messages

Counseling and placebo drug intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Cognitive behavioral cessation counseling

Intervention Type: BEHAVIORAL

Standard smoking cessation plus support text messages

Counseling and active drug intervention

Intervention Type: 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.

Interventions

Cognitive behavioral cessation counseling

Standard smoking cessation plus support text messages

Intervention Type: BEHAVIORAL

Counseling and placebo drug intervention

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn Pollak, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center - Cancer Prevention, Detection and Control

Durham, North Carolina, United States

Countries

United States

References

Pollak KI, Oliver JA, Pieper C, Davis JM, Gao X, Noonan D, Kennedy D, Granados I, Fish LJ. Cue-based treatment for light smokers: A proof of concept pilot. Addict Behav. 2021 Mar;114:106717. doi: 10.1016/j.addbeh.2020.106717. Epub 2020 Oct 17.

Reference Type: DERIVED

PMID: 33109394 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00089760

Identifier Type: -

Identifier Source: org_study_id