Chronic Pain and Opioid Dependence Assessment and Treatment

Chronic Pain Clinical Trial

— CPODAT  

Official title:

Chronic Pain and Opioid Dependence Assessment and Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727675
• Other study ID #: 0703002496
• Secondary ID: 1K23DA024050-01A
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: July 2015

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).

Description:

To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain intensity and pain interference on self-report measures from baseline throughout treatment) for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative feedback from individual exit interviews, and c) develop and modify initial therapist training and process rating measures. Products will include a) a manual for integrated CBT for POD to be used in opioid treatment programs and primary care settings with POD patients, b) therapist training materials, and c) process rating instruments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• at least 18 years of age

• currently in Methadone Maintenance Treatment (MMT) at the APT Foundation in New Haven, CT

• opioid dependence

• experience moderate to severe chronic pain

Exclusion Criteria:

• current suicide or homicide risk

• are unable to complete the informed consent or surveys because of psychiatric impairment

• have cognitive impairment

• are unable to read or understand English

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Dependency
• Opioid-Related Disorders

Intervention

Behavioral:
• Integrated Cognitive Behavioral Therapy
CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced illicit opioid use and pain		12 weeks