Evaluating the Chain of Addiction Care (CAC)

• Conditions: Substance Use Disorders; Hepatitis C, Chronic

• Registration Number: NCT05401136
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The investigators want to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. Secondary objective: to measure the impact of hepatitis C clearance on MET (+metabolite) and BUP (+metabolite) trough levels in patients on Opioid substitution Therapy (OST). This is an exploratory, observational study.

Detailed Description

People who (have) inject(ed) drugs (PWID) are at high risk for hepatitis C infection. Establishing adequate linkage to care in this population can be a challenge. Many of these patients receive opioid substitution, hepatitis C treatment possibly influences pharmacokinetics of those substitutes. This protocol describes a study on hepatitis C in people who (have) inject(ed) drugs (PWID), consisting of two substudies. 1) An exploratory, observational study in which we evaluate the decentralised hepatitis C care pathway in addiction care centres. 2) An observational pharmacokinetic study in hepatitis C patients on opioid substitution therapy (OST) embedded within the first study.

Rationale: 1) Many PWIDs are lost during the process of testing and linkage to care and do therefore not receive adequate hepatitis C treatment. Decentralising care in addiction care centres deems hospital visits unnecessary, an approach that has become increasingly popular in this population over the last few years. This practice however has not yet been evaluated in the Netherlands. 2) In the Netherlands the PWID population is often treated for opioid addiction by opioid substitution therapy (OST) with methadone (MET) or buprenorphine (BUP). There is evidence that liver inflammation has a negative effect on pharmacokinetics of drugs. Consequently, we hypothesize that HCV treatment results in reduced liver inflammation and a decrease in MET and/or BUP levels, which is clinically relevant in the PWID/OST population.

Objective: 1) to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. 2. to measure the impact of hepatitis C clearance on MET (+metabolites) and BUP (+metabolites) levels and craving in patients on OST.

Study design: This is an exploratory, observational study with a pharmacokinetic observational study embedded within the same population.

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Aged 18 years or older
• Able and willing to give informed consent
• Currently inject or previously injected drugs at least once, including nasal snorting of drugs using aids such as basepipes or straws.
• Visit the participating addiction care centre at least once during the study period

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCV prevalence (both anti-HCV and HCV RNA).	At screening (week 0)	Participants are invited to undergo viral hepatitis screening (standard care)
Treatment acceptance rate.	After evaluation (~week 3)	Participants with chronic HCV infection are invited to be treated (standard care)
Sustained virologic response	12 weeks after treatment (~week 30)	Participants who were treated and were 'cured' (standard care)

Secondary Outcome Measures

Name	Time	Method
Change in dosage of MET and BUP during follow-up	through study completion, an average of 1 year	Physician initiated dosage change before compared to after treatment of hepatitis C
Patient reported drug use	through study completion, an average of 1 year	Drug use during study timeframe
Re-infection rate.	through study completion, an average of 1 year	Patients re-infected after successful treatment
Acceptance rate of on-site testing.	through study completion, an average of 1 year	Number of participants that engage in testing
Mean decrease in MET and BUP trough levels	through study completion, an average of 1 year	Difference in concentration of methadone or buprenorphine before and after treatment.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands