Building Collaborations to Address Drug Problems in the United States and China

Chronic Pain Clinical Trial

Official title:

Building Collaborations to Address Drug Problems in the United States and China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021030
• Other study ID #: HUM00122412
• Status: Completed
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: January 6, 2021

Study information

• Verified date: April 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention on the distribution and variability of pain level before and after intervention receipt among people with co-occurring chronic pain and Substance Use Disorders (SUDs) over a three-month follow-up period.

Description:

The project is an open trial of the CBT intervention for 20 adults receiving detoxification treatment with comorbid pain. Participants will be screened for pain and other conditions by completing a self-report survey questionnaire. Eligible participants will be asked to complete a baseline assessment. A trained research therapist will conduct individual therapy with participants twice a week for 2-4 weeks. Participants will be re-assessed at 1- and 3-month post-intervention follow-ups to track changes in their pain, functioning, and substance use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Currently receiving detoxification treatment

• Report pain of at least moderate or greater intensity over the three months prior to baseline assessment as indicated by an average score of four or greater on the Numeric Rating Scale (NRS)

• Have access to a phone for confidential personal therapy after the completion of detoxification treatment. For individuals who enter the residential treatment at the facility following the detoxification treatment, a research therapist will meet with them in person at a private office at the facility during their stay due to program's restriction on phone usage.

Exclusion Criteria:

• Inability to speak and understand English

• Inability to give informed, voluntary, written consent

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)
The therapeutic intervention consists of 8, one-hour individual therapy sessions delivered over the course of 2 to 4 weeks with a trained CBT therapist. These sessions are designed to provide beneficial coping strategies that are helpful in dealing with both chronic pain and substance use.

Locations

Country	Name	City	State
United States	Meridian Health Services	Waterford	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Meridian Health Services, Michigan Medicine - PKUHSC Joint Institute for Translational and Clinical Research, Peking University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with decrease in pain level = 18 % (or two points) on the Numeric Rating Scale (NRS)	Pain level will be assessed using the Numeric Rating Scale (NRS). The NRS is a 0-10 scale, with higher scores indicating greater intensity of pain.	3 months post-intervention