Smoking Cessation for People Living With HIV/AIDS

NCT01965405 | Unknown DMC

• 1 other identifier: 1R01DA034537-01A1
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke).

1. 1.Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
2. 2.Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points.
3. 3.Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.

Conditions

HIV; AIDS; Nicotine Dependence

Keywords

HIV; AIDS; Nicotine Dependence; Smoking; Smoking cessation; Contingency Management

Outcome Measures

Primary Outcomes (4)

• Urinary Cotinine

  Urinary cotinine is a metabolite of nicotine, and can be detected in urine. The presence of cotinine in urine shows recent cigarette smoking. Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale. Declining scores show an individual has stopped or significantly reduced their smoking.

  Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)

• Longest Duration of Continuous Abstinence

  This is the longest period of consecutive days during treatment where the participant has not smoked. Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).

  Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)

• Seven-Day Point-Prevalence

  At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days. They will also participate in cotinine and carbon monoxide testing. Negative scores are given when the participant reports no smoking and all tests are negative.

  Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.

• Carbon Monoxide Results

  Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader. Carbon monoxide is produced when substances (such as cigarettes) are burned. Thus this test can show if an individual has been smoking recently.

  Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)

Study Arms (6)

Phase 1: Standard of Care (A)

EXPERIMENTAL

Brief counseling and bupropion

Drug: Bupropion; Behavioral: Brief Counseling

Phase 1: Standard of Care (B)

EXPERIMENTAL

Brief counseling, bupropion, and brief high-magnitude prize contingency management.

Drug: Bupropion; Behavioral: Brief Counseling; Behavioral: High-magnitude prize contingency management

Phase 2a Non-Responders (A)

EXPERIMENTAL

Bupropion, continued counseling, monitored support to quit smoking.

Drug: Bupropion; Behavioral: Brief Counseling; Behavioral: Monitored support to quit smoking

Phase 2a: Non-Responders (B)

EXPERIMENTAL

Bupropion, monitored support to quit smoking, prize contingency management for abstinence.

Drug: Bupropion; Behavioral: Monitored support to quit smoking; Behavioral: Prize contingency management for abstinence

Phase 2b: Responders (A)

EXPERIMENTAL

Bupropion, no additional treatment.

Drug: Bupropion; Behavioral: No additional treatment

Phase 2b: Responders (B)

EXPERIMENTAL

Bupropion, continued monitoring and low intensity prize contingency management.

Drug: Bupropion; Behavioral: Monitored support to quit smoking; Behavioral: Low intensity prize contingency management

Interventions

Bupropion DRUG

Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.

Also known as: Bupropion hydrochloride, Wellbutrin, Zyban

Phase 1: Standard of Care (A); Phase 1: Standard of Care (B); Phase 2a Non-Responders (A); Phase 2a: Non-Responders (B); Phase 2b: Responders (A); Phase 2b: Responders (B)

Brief Counseling BEHAVIORAL

Participants are provided with brief counseling for smoking cessation.

Phase 1: Standard of Care (A); Phase 1: Standard of Care (B); Phase 2a Non-Responders (A)

High-magnitude prize contingency management BEHAVIORAL

Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.

Phase 1: Standard of Care (B)

Monitored support to quit smoking BEHAVIORAL

Brief supportive sessions and monitoring of smoking cessation efforts.

Phase 2a Non-Responders (A); Phase 2a: Non-Responders (B); Phase 2b: Responders (B)

No additional treatment BEHAVIORAL

No additional treatment will be given.

Phase 2b: Responders (A)

Prize contingency management for abstinence BEHAVIORAL

Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.

Phase 2a: Non-Responders (B)

Low intensity prize contingency management BEHAVIORAL

Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.

Phase 2b: Responders (B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Able to read and understand English
• Smoke more than 10 cigarettes/day
• Patient enrolled in the HIV clinic with HIV or AIDS diagnosis

You may not qualify if:

• Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
• Are in recovery for pathological gambling (PG)
• Have contraindications for bupropion treatment (e.g., presence of epilepsy or other seizure disorder, use of monoamine oxidase inhibitors or other antidepressants, presence of eating disorders or very low weight)
• Are already participating in other smoking cessation interventions.

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• Ledgerwood DM, Lundahl LH, Greenwald MK, Cohn J, Arfken CL. Prize-Based Incentives for Smoking Cessation Among People With HIV: A Sequential Multiple Assignment Randomized Trial. Nicotine Tob Res. 2025 Apr 22;27(5):893-902. doi: 10.1093/ntr/ntae243.

  PMID: 39404754 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tobacco Use Disorder; Smoking; Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

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; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• David Ledgerwood, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 18, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

US (1)