Smoking, HIV Infections
Conditions
Keywords
HIV, Positive, Smokers, Varenicline
Brief summary
People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.
Detailed description
HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.
Interventions
1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.
DRUGNicotine Replacement Therapy
Nicotine gum and nicotine patch
OTHERBiological Control
No treatment intervention only information and procedures.
BEHAVIORALMotivational Interview
60 minute one-on-one Interview
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Philip Diaz
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age and older; 2. diagnosis of HIV; 3. self-reported smoking on a daily basis; 4. provide informed written consent
Exclusion criteria
1. persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam) 2. unable to understand spoken English 3. age less than 18 years. 4. pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Safety of Varenicline in PLWH Who Smoke | 3 months | To determine the safety and tolerability of varenicline compared to nicotine replacement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | 12 months | To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Replacement Plus Motivational Interviewing PLWH who smoke
12 week intervention with telephone counseling plus:
Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg) | 110 |
| Varenicline Plus Motivational Interviewing PLWH who smoke
12 week intervention with telephone counseling plus:
Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily | 118 |
| Total | 228 |
Baseline characteristics
| Characteristic | Nicotine Replacement Plus Motivational Interviewing | Varenicline Plus Motivational Interviewing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants | 118 Participants | 228 Participants |
| Age, Continuous | 42.7 years | 42.8 years | 42.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants | 117 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 40 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 55 Participants | 72 Participants | 127 Participants |
| Region of Enrollment United States | 110 Participants | 118 Participants | 228 Participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 93 Participants | 101 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 118 |
| other Total, other adverse events | 56 / 110 | 94 / 118 |
| serious Total, serious adverse events | 0 / 110 | 1 / 118 |
Outcome results
Primary
To Determine the Safety of Varenicline in PLWH Who Smoke
To determine the safety and tolerability of varenicline compared to nicotine replacement
Time frame: 3 months
Population: Three-month abstinence rates among participants who received NRT were compared with those who received varenicline. Although some participants stopped taking the pharmacotherapy, or switched from varenicline to NRT, for the analysis , they were kept in their initial group. Because treatment assignment was not random, inverse probability of treatment weighting (IPTW) adjustment was performed. A propensity score was estimated as the probability of receiving varenicline, given measured covariates
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Insomnia | 11 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Suicidal ideation | 0 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Vomiting | 3 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Depressed mood | 0 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Vivid dreams | 11 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Skin rash | 17 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Nausea | 13 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Skin rash | 0 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Nausea | 38 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Vomiting | 4 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Insomnia | 8 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Vivid dreams | 27 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Suicidal ideation | 1 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Safety of Varenicline in PLWH Who Smoke | Depressed mood | 8 Participants |
Secondary
To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline
Time frame: 12 months
Population: Abstinence rates among participants who received NRT were compared with those who received varenicline. Although some participants stopped taking the pharmacotherapy, or switched from varenicline to NRT, for the analysis , they were kept in their initial group. Because treatment assignment was not random, inverse probability of treatment weighting (IPTW) adjustment was performed. A propensity score was estimated as the probability of receiving varenicline, given measured covariates
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | 3 month biochemically confirmed abstinence rate | 13 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | 6 month biochemically confirmed abstinence rate | 5 Participants |
| Nicotine Replacement Plus Motivational Interviewing | To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | 12 month biochemically confirmed abstinence rate | 4 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | 3 month biochemically confirmed abstinence rate | 30 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | 6 month biochemically confirmed abstinence rate | 19 Participants |
| Varenicline Plus Motivational Interviewing | To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | 12 month biochemically confirmed abstinence rate | 18 Participants |