Phase 3
Completed N=136
Smoking Termination Enhancement Project (STEP)
Source: ClinicalTrials.gov NCT01065506 ↗Enrolled (actual)
136
Serious AEs
1.5%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day — 5; 9; 4; 9 number of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day |
5; 9; 4; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Aged between 18 and 65 years old
- Capable of providing informed consent, attend all study visits and comply with the protocol
- Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
- Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
- Score of 20 or greater on 16-item Anxiety Sensitivity Index
- 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
- Use of other tobacco products
- General medical condition(s) that contraindicate exercise
- Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
- 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)
- Body mass index ≥40
- Currently suicidal or high suicide risk
- 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
- Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding
- Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months
- 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
- Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.
Data sourced from ClinicalTrials.gov (NCT01065506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.