Chronic Pain and Opioid Dependence Assessment and Treatment

NCT ID: NCT00727675

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2015-07-31

Brief Summary

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

Detailed 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.

Conditions

Chronic Pain; Opioid Dependency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence.

Group Type: OTHER

Integrated Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Declan T. Barry, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

References

Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.

Reference Type: DERIVED

PMID: 27574837 (View on PubMed)

Other Identifiers

1K23DA024050-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0703002496

Identifier Type: -

Identifier Source: org_study_id