Smoking Cessation
Conditions
Keywords
Smoking Cessation, HIV, Cognition
Brief summary
This study tests whether withdrawal-related cognitive deficits increase smoking relapse among HIV-infected (HIV+) vs. HIV-uninfected smokers (HIV-). Adult smokers (N=300; 150 HIV+, 150 HIV-) will complete 2 sessions to assess cognition (24h abstinence vs. smoking-as-usual; order counterbalanced; weeks 0-2). Subjects will then receive smoking cessation counseling and open label transdermal nicotine (weeks 3-12). Outcomes are: 1) cognition; and 2) abstinence rates at the end-of-treatment.
Detailed description
Medical advances in the treatment of HIV/AIDS have improved the life expectancy of HIV-infected individuals. Unfortunately, HIV-infected individuals are three times more likely to use tobacco than those in the general population, but little is known about the mechanisms that underlie these high smoking rates. This will be the first study to test whether the neurocognitive impairments associated with HIV-1 infection may be exacerbated during nicotine withdrawal and increase the probability of smoking relapse among HIV-infected smokers (HIV+), compared to HIV-uninfected smokers (HIV-). To this end, adult treatment-seeking smokers (N=300; 150 HIV+ and 150 HIV-) will complete this 12-week study, which is divided into two phases: a pre-quit laboratory phase (weeks 0-2) and a treatment phase (weeks 3-12). Subjects will complete two laboratory sessions during the pre-quit phase: once following 24 hours of mandatory smoking abstinence and once while smoking-as-usual (order counterbalanced). A comprehensive cognitive task battery assessing memory, attention, and executive function will be administered during each laboratory session. During the treatment phase, all subjects will receive standard smoking cessation treatment, including counseling (weeks 3-8) and open-label transdermal nicotine (TN) patches (weeks 4-12). The primary outcomes are: 1) cognitive performance following 24-hours smoking abstinence (vs. smoking-as-usual) during the pre-quit phase; and 2) 7-day point-prevalence, biochemically-confirmed abstinence rates at the end-of-treatment (EOT) for the treatment phase.
Interventions
DRUGNicotine patch
All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use the patch in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
BEHAVIORALBehavioral counseling
Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average. * HIV status 1. HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 12 months prior to enrollment. 2. HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test. * Able to use transdermal nicotine (TN) safely, based on a medical evaluation. * Residing in the geographic area for at least 4 months. * Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are in the study and using transdermal nicotine. * Able to communicate fluently in English. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.
Exclusion criteria
Smoking Behavior 1. Current enrollment or plans to enroll in another smoking cessation program in the next 4 months. 2. Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes. 3. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 4 months. Alcohol/Drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function | Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12) | Cognitive function will be assessed at the Lab session 1 and lab session 2 visits as well as End of Treatment. Participants will complete measures of executive function, verbal learning and memory and response inhibition. The primary outcome is the change in cognitive function lab session 1, lab session 2, and End of Treatment measured by a composite score (calculated by averaging individual z-scores). Z-scores were calculated using the Stroop interference score (executive function; measured in milliseconds), the delayed recall score from the Hopkins Verbal Learning Test (verbal learning and memory), and the Stop signal reaction time from the Stop Signal Task (response inhibition, measured in milliseconds). A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Abstinence | End of Treatment (week 12) | Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 12). The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by carbon monoxide \< 5 ppm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV+ HIV-infected smokers: diagnosed with HIV infection and exhibiting viral load of less than or equal to 1000 copies/mL and CD4+ counts of greater than or equal to 200 cells/mm3 within 6 months prior to enrollment
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use the patch in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC). | 93 |
| HIV- HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test
Nicotine patch: All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use the patch in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks.
Behavioral counseling: Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC). | 181 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Lab Session 1 (Week 1) | Protocol Violation | 0 | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Total | HIV+ | HIV- |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 5 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 254 Participants | 88 Participants | 166 Participants |
| Age, Continuous | 51.9 years STANDARD_DEVIATION 10.7 | 52.4 years STANDARD_DEVIATION 9.4 | 51.6 years STANDARD_DEVIATION 11.4 |
| Cigarettes per day | 12.7 cigarettes per day STANDARD_DEVIATION 6 | 11.6 cigarettes per day STANDARD_DEVIATION 5.4 | 13.3 cigarettes per day STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 261 Participants | 87 Participants | 174 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 209 Participants | 84 Participants | 125 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) White | 42 Participants | 3 Participants | 39 Participants |
| Region of Enrollment United States | 274 participants | 93 participants | 181 participants |
| Sex: Female, Male Female | 109 Participants | 29 Participants | 80 Participants |
| Sex: Female, Male Male | 165 Participants | 64 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 127 |
| other Total, other adverse events | 32 / 80 | 36 / 127 |
| serious Total, serious adverse events | 0 / 80 | 2 / 127 |
Outcome results
Primary
Cognitive Function
Cognitive function will be assessed at the Lab session 1 and lab session 2 visits as well as End of Treatment. Participants will complete measures of executive function, verbal learning and memory and response inhibition. The primary outcome is the change in cognitive function lab session 1, lab session 2, and End of Treatment measured by a composite score (calculated by averaging individual z-scores). Z-scores were calculated using the Stroop interference score (executive function; measured in milliseconds), the delayed recall score from the Hopkins Verbal Learning Test (verbal learning and memory), and the Stop signal reaction time from the Stop Signal Task (response inhibition, measured in milliseconds). A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance.
Time frame: Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12)
Population: Numbers are different due to attrition between enrollment and lab session 1. Some cognitive data were excluded due to outliers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV+ Smoking Lab Session First | Cognitive Function | End of treatment (week 12) | 0.149 z-score | Standard Deviation 0.416 |
| HIV+ Smoking Lab Session First | Cognitive Function | Lab session 1 (week 1) | 0.125 z-score | Standard Deviation 0.489 |
| HIV+ Smoking Lab Session First | Cognitive Function | Lab session 2 (week 2) | .043 z-score | Standard Deviation 0.498 |
| HIV- Smoking Lab Session First | Cognitive Function | Lab session 1 (week 1) | -.093 z-score | Standard Deviation 0.441 |
| HIV- Smoking Lab Session First | Cognitive Function | End of treatment (week 12) | -.082 z-score | Standard Deviation 0.465 |
| HIV- Smoking Lab Session First | Cognitive Function | Lab session 2 (week 2) | -.012 z-score | Standard Deviation 0.441 |
| HIV+ Abstinent Lab Session First | Cognitive Function | End of treatment (week 12) | -.091 z-score | Standard Deviation 0.44 |
| HIV+ Abstinent Lab Session First | Cognitive Function | Lab session 1 (week 1) | -.059 z-score | Standard Deviation 0.452 |
| HIV+ Abstinent Lab Session First | Cognitive Function | Lab session 2 (week 2) | -.106 z-score | Standard Deviation 0.488 |
| HIV- Abstinent Lab Session First | Cognitive Function | End of treatment (week 12) | .001 z-score | Standard Deviation 0.559 |
| HIV- Abstinent Lab Session First | Cognitive Function | Lab session 2 (week 2) | .014 z-score | Standard Deviation 0.546 |
| HIV- Abstinent Lab Session First | Cognitive Function | Lab session 1 (week 1) | -.008 z-score | Standard Deviation 0.553 |
Secondary
7-day Point Prevalence Abstinence
Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 12). The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by carbon monoxide \< 5 ppm.
Time frame: End of Treatment (week 12)
Population: Only subjects who entered treatment following the two lab sessions were considered intent to treat and included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV+ Smoking Lab Session First | 7-day Point Prevalence Abstinence | 22 Participants |
| HIV- Smoking Lab Session First | 7-day Point Prevalence Abstinence | 33 Participants |