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Chronic Pain and Opioid Dependence Assessment and Treatment (CPODAT)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Declan Barry, Yale University
ClinicalTrials.gov Identifier:
NCT00727675
First received: July 31, 2008
Last updated: June 28, 2016
Last verified: June 2016

July 31, 2008
June 28, 2016
August 2008
July 2014   (final data collection date for primary outcome measure)
Reduced illicit opioid use and pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00727675 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Chronic Pain and Opioid Dependence Assessment and Treatment
Chronic Pain and Opioid Dependence Assessment and Treatment
This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).
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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Pain
  • Opioid Dependency
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.
1
Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence.
Intervention: Behavioral: Integrated Cognitive Behavioral Therapy
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 Aug 30. doi: 10.4088/JCP.15m09963. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00727675
1K23DA024050-01A1
No
Not Provided
Not Provided
Declan Barry, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Declan T. Barry, Ph.D. Yale University
Yale University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP