HCV-Smoking Cessation Study

NCT05466981 | Completed

• 1 other identifier: 00103095
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A 12-week study for patients who are being treated for Hepatitis C and would like to quit smoking. During the 12 weeks of Hepatitis C treatment, the research team will have counseling sessions with the participants to discuss challenges related to Hepatitis C and smoking.

Conditions

Hepatitis C; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Change in the number of cigarettes smoked per day (CPD)

  We will track the number of cigarettes the participant smokes per day at each weekly visit, then compare the CPD at baseline during week 0 to the end of treatment at week 12.

  baseline (week 0) to end of treatment (week 12)

• Change in Fagerstrom Test for Nicotine Dependence (FTND) score

  We will calculate the participant's FTND score at the baseline visit during week 0 and compare it to their FTND score at the end of treatment visit during week 12.

  baseline (week 0) to end of treatment (week 12)

Secondary Outcomes (2)

• Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score

  baseline (week 0) to end of treatment (week 12)

• Number of quit attempts

  baseline (week 0) to end of treatment (week 12)

Study Arms (1)

Current smokers with an HCV infection

EXPERIMENTAL

Persons who currently smoke cigarettes and are also HCV RNA+

Behavioral: Cognitive Behavioral Counseling

Interventions

Cognitive Behavioral Counseling BEHAVIORAL

The intervention consisted of 12 weeks of HCV treatment combined with smoking cessation pharmacotherapy and brief behavioral counseling conducted by a LMSW. The brief behavioral counseling consisted of cognitive behaioral components and was provided by phone and in-person. The intervention followed these 5 phases: increase motivation to quit smoking, quit attempt, maintain short-term abstinence, and lapse and relapse prevention.

Current smokers with an HCV infection

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years old)
• Current HCV infection (HCV RNA+)
• Current cigarette smoking
• Patients in contemplation / preparation stage of change

You may not qualify if:

• Inability to speak/read English, as materials will be provided in English
• Current suicidal ideation as determined by the PHQ-9, requiring a greater level of clinical care
• Severe medical or psychiatric disability that prevents participant from ability to comprehend or consent to study

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health Internal Medicine Clinic

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Hepatitis C; Smoking Cessation

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Health Behavior; Behavior

Study Officials

• Irene Pericot-Valverde, PhD

  Prisma Health

  PRINCIPAL INVESTIGATOR

• Alain Litwin, MD

  Prisma Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We conducted a single-arm pilot study in order to test the feasibility and preliminary efficacy of a smoking cessation intervention for people with HCV while they received standard of care treatment: antiviral medication and provider/laboratory visits.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 20, 2022
• Study Start: November 23, 2020
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: July 20, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)