Project Q Pilot: Smoking Cessation for Light Smokers

Tobacco Use Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416621
• Other study ID #: Pro00089760
• Status: Completed
• Phase: Phase 3
• Start date: May 17, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• Cognitive behavioral cessation counseling
Standard smoking cessation plus support text messages
• Counseling and placebo drug intervention
Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo

Drug:
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center - Cancer Prevention, Detection and Control	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Validated Cessation	Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.	1 week post-intervention