Tobacco Use Cessation
Conditions
Keywords
Light Smoker
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.
Interventions
BEHAVIORALCognitive behavioral cessation counseling
Standard smoking cessation plus support text messages
BEHAVIORALCounseling and placebo drug intervention
Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
DRUGCounseling 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Validated Cessation | 1 week post-intervention | Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Cue-based Treatment Enhanced cue exposure treatment (lab-based + interactive SMS texting)
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages | 13 |
| Comparator: Standard Counseling Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages | 11 |
| 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.
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
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. | 3 |
| Total | 27 |
Baseline characteristics
| Characteristic | Total | Active Comparator: Counseling and Active Drug Intervention | Comparator: Standard Counseling | Experimental: Cue-based Treatment |
|---|---|---|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 16.2 | 43 years STANDARD_DEVIATION 24 | 44.2 years STANDARD_DEVIATION 18.4 | 42.3 years STANDARD_DEVIATION 14.8 |
| Cigarettes per day | 6.1 cigarettes per day STANDARD_DEVIATION 2.2 | 7 cigarettes per day STANDARD_DEVIATION 3.6 | 6.5 cigarettes per day STANDARD_DEVIATION 2 | 5.8 cigarettes per day STANDARD_DEVIATION 2.5 |
| Education: Some college or college grad | 20 Participants | 3 Participants | 9 Participants | 8 Participants |
| Employment status: Employed | 10 Participants | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 3 Participants | 10 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Native Light Smoker | 17 Participants | 2 Participants | 8 Participants | 7 Participants |
| Nicotine Dependence | 2.5 units on a scale STANDARD_DEVIATION 1.9 | 1.7 units on a scale STANDARD_DEVIATION 2.9 | 2.3 units on a scale STANDARD_DEVIATION 1.7 | 2.8 units on a scale STANDARD_DEVIATION 2.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 2 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 19 Participants | 1 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 3 Participants | 3 Participants |
| Type of smoker Daily | 26 Participants | 3 Participants | 11 Participants | 12 Participants |
| Type of smoker Intermittent | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 | 0 / 6 |
| other Total, other adverse events | 0 / 13 | 0 / 12 | 0 / 6 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 | 0 / 6 |
Outcome results
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.
Time frame: Approximately 8 weeks
Population: The primary outcome was defined as acceptability across the entire sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Cue-based Treatment | Number of Participants Who Rated the Intervention Acceptable | 23 Participants |
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.
Time frame: Approximately 8 weeks
Population: Only one participant in the Active Comparator arm completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Cue-based Treatment | Number of Participants With Completion of at Least 2 Study Visits | 10 Participants |
| Control: Standard Counseling | Number of Participants With Completion of at Least 2 Study Visits | 7 Participants |
| Active Comparator: Counseling and Active Drug Intervention | Number of Participants With Completion of at Least 2 Study Visits | 1 Participants |
Secondary
Number of Participants With Validated Cessation
Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.
Time frame: 1 week post-intervention
Population: Only one participant in the Active Comparator arm completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Cue-based Treatment | Number of Participants With Validated Cessation | 2 Participants |
| Control: Standard Counseling | Number of Participants With Validated Cessation | 0 Participants |
| Active Comparator: Counseling and Active Drug Intervention | Number of Participants With Validated Cessation | 0 Participants |