Overlapping Buprenorphine Initiation (in Opioid Physical Dependence)

Chronic Pain Clinical Trial

Official title:

Overlapping Buprenorphine Initiation and Full Agonist Opioid Discontinuation Among Patients on High-dose Long-term Full Agonist Opioid Therapy Who Have Opioid Physical Dependence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04228250
• Other study ID #: PENDING
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2020
• Est. completion date: August 2021

Study information

• Verified date: January 2020
• Source: VA Connecticut Healthcare System
• Contact: William C Becker, MD
• Phone: 203-932-5711
• Email: William.Becker4[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial aims to assess the tolerability and effectiveness of overlapping buprenorphine initiation and full agonist opioid discontinuation among patients on high-dose long-term full agonist opioid therapy who have opioid physical dependence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 3 months or more of 50 mg morphine equivalent daily dose or more full agonist opioid therapy

• evaluated in a pain management or opioid reassessment clinic within the past 60 days

• interested in switching to buprenorphine from full agonist opioid therapy for pain

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Stepwise increase in buprenorphine while continuing full agonist opioid until buprenorphine reaches therapeutic dose
Stepwise increase in buprenorphine while continuing full agonist opioid with abrupt discontinuation of latter when buprenorphine reaches therapeutic dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adjective Rating Scale for Withdrawal score on Day 7 compared to baseline	Severity of 16 withdrawal symptoms will be recorded on a 9-point scale using the Adjective Rating Scale. Scores on the Scale can range from 16 to 144 with higher scores indicating more severe symptoms. The difference in scores on day 7 relative to baseline will be calculated as day 7 - baseline. Therefore, differences can range from -128 to 128 with negative change scores indicating improvement over baseline.	Day 7 following intervention
Secondary	Change in pain intensity on Day 7 compared to baseline	Difference in self-reported pain intensity using the PEG, calculated as day 7 - baseline. PEG scores range from 0 to 10 with lower scores indicating lower pain intensity. Therefore difference scores can range from -10 to 10, with negative change scores indicating improvement over baseline.	Day 7 following intervention
Secondary	Change in Adjective Rating Scale for Withdrawal score on Day 4 compared to baseline	Severity of 16 withdrawal symptoms will be recorded on a 9-point scale using the Adjective Rating Scale. Scores on the Scale can range from 16 to 144 with higher scores indicating more severe symptoms. The difference in scores on day 4 relative to baseline will be calculated as day 4 - baseline. Therefore, differences can range from -128 to 128 with negative change scores indicating improvement over baseline.	Day 4 following intervention
Secondary	Change in Adjective Rating Scale for Withdrawal score on Day 14 compared to baseline	Severity of 16 withdrawal symptoms will be recorded on a 9-point scale using the Adjective Rating Scale. Scores on the Scale can range from 16 to 144 with higher scores indicating more severe symptoms. The difference in scores on day 14 relative to baseline will be calculated as day 14 - baseline. Therefore, differences can range from -128 to 128 with negative change scores indicating improvement over baseline.	Day 14 following intervention