Varenicline for Nicotine Dependence Among Those With HIV/AIDS

NCT01710137 | Completed Phase 3 Results DMC

• 3 other identifiers: R01DA033681-01815435R01DA033681
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2) quality of life will be rated higher in the varenicline and counseling group versus the placebo and counseling group, and there will be no significant differences between treatment arms in terms of the frequency of severe varenicline-related side effects; and 3) improved affect and reduced cognitive impairment will mediate the effect of varenicline therapy on quit rates.

Conditions

Nicotine Dependence

Keywords

Smoking cessation; Nicotine dependence; Varenicline; Chantix; HIV; AIDS

Outcome Measures

Primary Outcomes (2)

• Point Prevalence Tobacco Abstinence

  7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.

  Week 12

• Point Prevalence Tobacco Abstinence

  7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.

  Week 24

Secondary Outcomes (5)

• Quality of Life at Week 12

  Week 12

• Continuous Abstinence to Week 12

  Weeks 12

• Continuous Abstinence to Week 24

  Weeks 24

• Time to 7-day Relapse

  Week 24

• Point Prevalence Tobacco Abstinence

  Week 18

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

12 weeks of active varenicline + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally

Drug: Varenicline; Behavioral: Smoking Cessation Counseling

Placebo

PLACEBO COMPARATOR

12 weeks of placebo + smoking cessation counseling Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally

Drug: Placebo; Behavioral: Smoking Cessation Counseling

Interventions

Varenicline DRUG

Also known as: Chantix

Varenicline

Placebo DRUG

Placebo

Smoking Cessation Counseling BEHAVIORAL

Placebo; Varenicline

Eligibility Criteria

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

You may qualify if:

• years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average.
• Diagnosed with HIV infection and exhibiting viral load of \< 1000 copies/mL and CD4+ counts of \> 200 cells/mm3 within 6 months prior to enrollment.
• Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
• Residing in the geographic area for at least 7 months.
• Women of childbearing potential (based on medical history and physical exam) 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 taking study medication and for at least one month after the medication period ends.
• If current or past diagnosis of bipolar disorder (I, II, or NOS), eligible if:
• No psychotic features
• MADRS: total score \< 8 (past 4 weeks), suicidal item score \< 1 (past 4 weeks)
• Y-MRS: total score \< 8 (past 4 weeks), irritability, speech content, disruptive, or aggressive behavior items score \< 3 (past 4 weeks)
• No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
• No aggressive or violent acts or behavior in the past 6 months
• 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 7 months.
• Regular (daily) use of 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 7 months.
• Note: Once participants are found eligible for the study, they are told they should refrain from using any nicotine replacement therapy (NRT) for the duration of the study. If a subject reports an isolated (non-daily) instance of NRT use during the study, they may be permitted to continue.
• Current untreated and unstable diagnosis of substance abuse or dependence (eligible if past use and if receiving treatment and stable for \>30 days).
• Positive urine drug screen (for cocaine and/or methamphetamines) at the Intake Session.
• Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the Intake Session.
• Current use or recent discontinuation (within last 14 days) of the following medications:
• Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)
• a. Note: Once participants are found eligible for the study, they are instructed to only use the smoking cessation medication provided to them by the study staff. If a subject reports an isolated (non-daily) instance of using a non-study smoking cessation medication, the study physician and PI will evaluate the situation and determine if it is safe for the subject to continue participation.
• Anti-psychotic medications.
• Women who are pregnant, planning a pregnancy within the next 7 months, or lactating.
• Current diagnosis of unstable and untreated major depression, as determined by self-report \& MINI (eligible if stable for \>30 days).
• Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.

Sponsors & Collaborators

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

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Ashare RL, Thompson M, Leone F, Metzger D, Gross R, Mounzer K, Tyndale RF, Lerman C, Mahoney MC, Cinciripini P, George TP, Collman RG, Schnoll R. Differences in the rate of nicotine metabolism among smokers with and without HIV. AIDS. 2019 May 1;33(6):1083-1088. doi: 10.1097/QAD.0000000000002127.

  PMID: 30946162 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Acquired Immunodeficiency Syndrome

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Robert Schnoll
• Organization: University of Pennsylvania

schnoll@pennmedicine.upenn.edu

215-746-7143

Study Officials

• Robert A Schnoll, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 18, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 18, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Locations

US (1)