Chronic Pain and Opioid Dependence Assessment and Treatment - Full Text View

Sponsors and Collaborators:	Yale University National Institute on Drug Abuse (NIDA)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00727675

Purpose

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

Condition	Intervention
Chronic Pain Opioid Dependency	Behavioral: Integrated Cognitive Behavioral Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Chronic Pain and Opioid Dependence Assessment and Treatment

Further study details as provided by Yale University:

Primary Outcome Measures:

Reduced illicit opioid use and pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence.	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727675

Contacts

Contact: Declan T. Barry, Ph.D.	203-781-4650 ext 268	declan.barry@yale.edu
Contact: Christopher Cutter, Ph.D.	203-781-4650	christopher.cutter@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Declan T. Barry, Ph.D.

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Declan Barry, Ph.D. )
Study ID Numbers:	1K23DA024050-01A1
Study First Received:	July 31, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00727675
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Yale University:

chronic pain
opioid dependence
Cognitive Behavioral Therapy (CBT)

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009