Chronic Pain and Opioid Dependence Assessment and Treatment (CPODAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Declan Barry, Yale University
ClinicalTrials.gov Identifier:
NCT00727675
First received: July 31, 2008
Last updated: January 13, 2014
Last verified: January 2014
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chronic Pain and Opioid Dependence Assessment and Treatment

Resource links provided by NLM:


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 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Declan T. Barry, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Declan Barry, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00727675     History of Changes
Other Study ID Numbers: 1K23DA024050-01A1
Study First Received: July 31, 2008
Last Updated: January 13, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Yale University:
chronic pain
opioid dependence
Cognitive Behavioral Therapy (CBT)

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 20, 2014