Cognition and Smoking Relapse (HCS)

NCT ID: NCT03169101

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 274 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2022-04-25

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.

Conditions

Smoking Cessation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV+ Smoking lab session first

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 Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second

Nicotine patch

Intervention Type: DRUG

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

Intervention Type: BEHAVIORAL

Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).

HIV- Smoking lab session first

HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test Randomized to complete smoking-as-usual lab session first and 24-h abstinent lab session second

Nicotine patch

Intervention Type: DRUG

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

Intervention Type: BEHAVIORAL

Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).

HIV+ Abstinent lab session first

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 Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second

Nicotine patch

Intervention Type: DRUG

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

Intervention Type: BEHAVIORAL

Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).

HIV- Abstinent lab session first

HIV-uninfected smokers: negative HIV status will be confirmed by an on-site rapid HIV blood test Randomized to complete 24-h abstinent lab session first and smoking-as-usual lab session second

Nicotine patch

Intervention Type: DRUG

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

Intervention Type: BEHAVIORAL

Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).

Interventions

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.

Intervention Type: DRUG

Behavioral counseling

Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).

Intervention Type: BEHAVIORAL

Other Intervention Names

Nicoderm CQ

Eligibility Criteria

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.

1. Current untreated and unstable diagnosis of substance dependence (eligible if past use and if receiving treatment and stable for at least 30 days). Current untreated and unstable diagnosis of substance abuse requires Study Physician approval.

2. A positive urine drug screen for cocaine, amphetamines, methamphetamines, Phencyclidine (PCP), barbiturates, ecstasy (MDMA) at Intake (see Measures and Table 1 for details). At Lab 1 and Lab 2, positive urine drug screens will be reviewed on a case-by-case basis. The PI will determine if the participant will be excluded or allowed to reschedule the visit, at which time they must provide a negative drug screen to continue with the study.

Current use or recent discontinuation (within last 14 days) of the following medications:

1. Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin sustained release (SR), Chantix)

a. Note: Once participants are found eligible for the study, they are instructed to only use the NRT provided to them by the study staff. If a subject reports using a non-study smoking cessation medication (including other forms of NRT), the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.

2. Anti-psychotic medications (if used to treat psychotic symptoms. Other uses may be eligible pending physician approval).

3. Daily use of opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin). Smokers who report taking opiate-containing medications on an "as-needed" basis will be instructed to refrain from use until their study participation is over and that they will be tested to ensure they have complied with this requirement.

4. Asthma medications/corticosteroids (requires physician approval)

5. Anti-depressants (require physician approval)

1. Females who self-report current pregnancy, planning a pregnancy during the study, or currently breastfeeding/lactating.

2. Current diagnosis of unstable and untreated major depression, as determined by self-report & Mini International Neuropsychiatric Interview (MINI) (eligible if stable for at least 30 days).

3. Current or past diagnosis of bipolar disorder or psychotic disorder, as determined by self-report or MINI.

4. History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable, requires Study Physician approval).

5. Uncontrolled hypertension (systolic blood pressure (SBP) greater than 160 or diastolic blood pressure (DBP) greater than 100) present at Intake.

a. Note: If a participant presents with blood pressure greater than 160/100 at sessions occurring on Week 3 (Pre-Quit) or at any other point during the treatment period, they will not be provided with/able to continue on TN unless the study physician grants approval.

6. Previous allergic reaction to TN.

7. History of diabetes (requires Study Physician approval)

8. History of seizures (requires Study Physician approval)

9. History of stomach ulcers (requires Study Physician approval)

1. Suicide risk as indicated by at least one of the following on the Columbia Suicide Severity Rating Scale (the PI &/or study psychologist will be consulted to assess safety and determine eligibility in cases close to the eligibility cutoffs):

1. Current suicidal ideation (within 30 days of enrollment)

2. Two or more lifetime suicide attempts

3. Any suicide attempt within 2 years of enrollment

1. Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.

2. Color blindness.

3. Any impairment (physical and/or neurological) including visual or other impairment preventing cognitive task performance.

4. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca L Ashare, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Greene B, Schnoll RA, Gross R, Ashare RL. The role of alternative reinforcers in smoking outcomes among people with and without HIV. Psychol Addict Behav. 2025 Jun 5:10.1037/adb0001071. doi: 10.1037/adb0001071. Online ahead of print.

Reference Type: DERIVED

PMID: 40471817 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DA042682

Identifier Type: NIH

Identifier Source: secondary_id

View Link

824860

Identifier Type: -

Identifier Source: org_study_id