N/A
Completed N=53
Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
Nicotine Dependence · Symptoms of Anxiety · HIV
Source: ClinicalTrials.gov NCT01393301 ↗
Enrolled (actual)
53
Serious AEs
9.4%
Results posted
Mar 2019
Primary outcomePrimary: Treatment Acceptability — 17 Participants
Summary
During the 1-year formative phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (N = up to 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. The goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. During the two-year pilot RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral and pharmacological smoking cessation intervention for HIV+ smokers with interfering psychological distress.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Acceptability |
17 | — |
| PRIMARY Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) |
6; 1 | — |
| PRIMARY Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) |
10; 2 | — |
| SECONDARY Treatment Related Changes in Psychological Distress. |
-.06; .31 | — |
Eligibility Criteria
Inclusion Criteria
- 18-65 years old
- Informed consent
- Daily smoker
- Motivated to quit smoking
Exclusion Criteria
- Use of other tobacco products
- Untreated or unstable psychiatric disorders
- Current use of cognitive-behavioral therapy or medication for smoking cessation treatment
- Insufficient command of English
Data sourced from ClinicalTrials.gov (NCT01393301). 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.