Smoking Cessation Using Motivational Therapy and Varenicline

NCT ID: NCT00701896

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-03
• Study Completion Date: 2013-06-20

Brief Summary

People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.

Detailed Description

HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.

Conditions

Smoking; HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy Control - Non-smoking

Healthy Control arm with 51 subjects who are HIV negative and do not smoke

Group Type: OTHER

Biological Control

Intervention Type: OTHER

No treatment intervention only information and procedures.

Healthy Control - Smoker

Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.

Group Type: OTHER

Biological Control

Intervention Type: OTHER

No treatment intervention only information and procedures.

HIV Smoking Cessation Arm

Includes up to 365 subjects who are HIV positive and initiate smoking cessation

Group Type: ACTIVE_COMPARATOR

Varenicline tartrate

Intervention Type: DRUG

1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.

Nicotine Replacement Therapy

Intervention Type: DRUG

Nicotine gum and nicotine patch

Motivational Intervention

Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention

Group Type: EXPERIMENTAL

Motivational Interview

Intervention Type: BEHAVIORAL

60 minute one-on-one Interview

Interventions

Varenicline tartrate

1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.

Intervention Type: DRUG

Nicotine Replacement Therapy

Nicotine gum and nicotine patch

Intervention Type: DRUG

Biological Control

No treatment intervention only information and procedures.

Intervention Type: OTHER

Motivational Interview

60 minute one-on-one Interview

Intervention Type: BEHAVIORAL

Other Intervention Names

Chantix

Eligibility Criteria

Inclusion Criteria

1. 18 years of age and older;

2. diagnosis of HIV;

3. self-reported smoking on a daily basis;

4. provide informed written consent

Exclusion Criteria

1. persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)

2. unable to understand spoken English

3. age less than 18 years.

4. pregnant women

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Philip Diaz

OTHER

Sponsor Role: lead

Responsible Party

Philip Diaz

Director, Pulmonary Rehabilitation Services; Medical Director, Respiratory Therapy; Associate Director, General Clinical Research Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Philip T. Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Other Identifiers

R01HL090313

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007H0173

Identifier Type: -

Identifier Source: org_study_id