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Completed

NCT Number: NCT00727675

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).

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Key information

Conditions

Chronic Pain Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Dependency Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Cognitive Behavioral Therapy

Behavioral

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

Primary outcomes

  1. Reduced illicit opioid use and pain

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: CPODAT

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Aug 4, 2008
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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