Smoking
Conditions
Brief summary
The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.
Interventions
BEHAVIORALCognitive Behavioral Treatment
Cognitive Behavioral Treatment
DRUGNicotine Patch
Nicotine Patch
BEHAVIORALWellness Program
Wellness Program
BEHAVIORALAerobic Exercise
Aerobic Exercise
Sponsors
National Institute on Drug Abuse (NIDA)
Southern Methodist University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged between 18 and 65 years old 2. Capable of providing informed consent, attend all study visits and comply with the protocol 3. Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day 4. Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale 5. Score of 20 or greater on 16-item Anxiety Sensitivity Index 6. Physically inactive as defined as participating in moderate-intensity exercise less than 2 days/week (duration must be 30 minutes or less each time)
Exclusion criteria
1. Use of other tobacco products 2. General medical condition(s) that contraindicate exercise 3. Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure 4. Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300 mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid levels above the cut-offs will be eligible with physician written approval) 5. Body mass index ≥40 6. Currently suicidal or high suicide risk 7. Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol 8. Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding 9. Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months 10. Psychotherapy initiated within the past three months, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or mood disorder other than general supportive therapy 11. Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day | End of treatment (10 weeks post quit day) and 30-week follow-up | Point Prevalence Abstinence (PPA) was defined as not smoking \[even a single puff\] at the end of treatment and/or on the day of follow-up |
Countries
United States
Participant flow
Pre-assignment details
Of the 150 enrolled participants, 7 participants completed a baseline assessment, then subsequently dropped out of the study before receiving any treatment. 7 participants were used as pilots. Accordingly, results are reported for the remaining 136 participants.
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Plus Wellness Program Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Wellness Program: Wellness Program | 64 |
| Standard Care Plus Exercise Program Cognitive Behavioral Treatment: Cognitive Behavioral Treatment
Nicotine Patch: Nicotine Patch
Aerobic Exercise: Aerobic Exercise | 72 |
| Total | 136 |
Baseline characteristics
| Characteristic | Standard Care Plus Wellness Program | Standard Care Plus Exercise Program | Total |
|---|---|---|---|
| Age, Continuous | 45.39 years STANDARD_DEVIATION 11.3 | 43.12 years STANDARD_DEVIATION 11.26 | 44.19 years STANDARD_DEVIATION 11.29 |
| ASI-3 | 18.63 units on a scale STANDARD_DEVIATION 10.36 | 18.04 units on a scale STANDARD_DEVIATION 12.72 | 18.32 units on a scale STANDARD_DEVIATION 11.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 49 Participants | 51 Participants | 100 Participants |
| Region of Enrollment United States | 64 participants | 72 participants | 136 participants |
| Sex: Female, Male Female | 36 Participants | 36 Participants | 72 Participants |
| Sex: Female, Male Male | 28 Participants | 36 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 72 |
| serious Total, serious adverse events | 1 / 64 | 1 / 72 |
Outcome results
Primary
Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
Point Prevalence Abstinence (PPA) was defined as not smoking \[even a single puff\] at the end of treatment and/or on the day of follow-up
Time frame: End of treatment (10 weeks post quit day) and 30-week follow-up
Population: Participants who completed the end of treatment assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Care Plus Wellness Program | Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day | End of treatment | 5 number of participants |
| Standard Care Plus Wellness Program | Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day | Follow-up (n=35, 34) | 4 number of participants |
| Standard Care Plus Exercise Program | Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day | End of treatment | 9 number of participants |
| Standard Care Plus Exercise Program | Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day | Follow-up (n=35, 34) | 9 number of participants |