Cognition and Smoking Relapse (HCS)

NCT03169101 | Completed Results FDA Drug

• 2 other identifiers: 824860R01DA042682
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; HIV; Cognition

Outcome Measures

Primary Outcomes (1)

• 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.

  Lab session 1 (week 1), lab session 2 (week 2), End of treatment (week 12)

Secondary Outcomes (1)

• 7-day Point Prevalence Abstinence

  End of Treatment (week 12)

Study Arms (4)

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

Drug: Nicotine patch; Behavioral: Behavioral counseling

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

Drug: Nicotine patch; Behavioral: Behavioral counseling

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

Drug: Nicotine patch; Behavioral: Behavioral counseling

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

Drug: Nicotine patch; Behavioral: Behavioral counseling

Interventions

Nicotine patch 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.

Also known as: Nicoderm CQ

HIV+ Abstinent lab session first; HIV+ Smoking lab session first; HIV- Abstinent lab session first; HIV- Smoking lab session first

Behavioral counseling BEHAVIORAL

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

HIV+ Abstinent lab session first; HIV+ Smoking lab session first; HIV- Abstinent lab session first; HIV- Smoking lab session first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Three hundred (150 HIV+ and 150 HIV-) adult male and female smokers 18 years of age or older who smoke at least 5 cigarettes per day and are interested in quitting smoking will complete the study. HIV-infected smokers have been diagnosed with HIV/AIDS and HIV-uninfected smokers will have no diagnosis of HIV, either via blood test or self-report.

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• Smoking Behavior
• Current enrollment or plans to enroll in another smoking cessation program in the next 4 months.
• Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
• Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 4 months.
• 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.
• 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:
• 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.
• Anti-psychotic medications (if used to treat psychotic symptoms. Other uses may be eligible pending physician approval).
• 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.
• Asthma medications/corticosteroids (requires physician approval)
• Anti-depressants (require physician approval)
• Females who self-report current pregnancy, planning a pregnancy during the study, or currently breastfeeding/lactating.
• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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 Nov;39(7):632-643. doi: 10.1037/adb0001071. Epub 2025 Jun 5.

  PMID: 40471817 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Two samples (one 10 mL and one 8 mL) of blood will be drawn at the Intake visit to evaluate the nicotine metabolite ratio and neuroinflammatory markers. All specimens are to be collected solely for research purposes.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine; Behavior Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Rebecca Ashare, PhD
• Organization: University of Pennsylvania

rlashare@pennmedicine.upenn.edu

7168296273

Study Officials

• Rebecca L Ashare, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 30, 2017
• Study Start: July 1, 2016
• Primary Completion: April 21, 2022
• Study Completion: April 25, 2022
• Last Updated: May 10, 2024
• Results First Posted: May 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)