HCV-Smoking Cessation Study

Hepatitis C Clinical Trial

Official title:

Smoking Cessation Intervention for Persons Infected With Hepatitis C Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466981
• Other study ID #: 00103095
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: November 11, 2021

Study information

• Verified date: July 2021
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A 12-week smoking cessation intervention addressing concurrently HCV and smoking cessation The Standard of care for HCV is 12 weeks of oral medication with 3 in-person provider/laboratory visits throughout. This study utilizes both in-person and phone counseling and health education sessions. Each session will address a different topic related to HCV, smoking, and how both smoking and HCV affect health and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (=18 years old)

• Current HCV infection (HCV RNA+)

• Current cigarette smoking

• Patients in contemplation / preparation stage of change

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Smoking Cessation

Intervention

Behavioral:
• Cognitive Behavioral Counseling
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.

Locations

Country	Name	City	State
United States	Prisma Health Internal Medicine Clinic	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score	We will calculate the participant's PHQ-9 score at the baseline visit during week 0 and compare it to their PHQ-9 score at the end of treatment visit during week 12.	baseline (week 0) to end of treatment (week 12)
Secondary	Number of quit attempts	We will measure the number of quit attempts made throughout the intervention from baseline to end of treatment.	baseline (week 0) to end of treatment (week 12)