NCT00727675

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

5.9 years

First QC Date

July 31, 2008

Last Update Submit

April 1, 2020

Conditions

Chronic PainOpioid Dependency

Keywords

chronic painopioid dependenceCognitive Behavioral Therapy (CBT)

Outcome Measures

Primary Outcomes (1)

  • Reduced illicit opioid use and pain

    12 weeks

Study Arms (1)

1

OTHER

Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence.

Behavioral: Integrated Cognitive Behavioral Therapy

Interventions

Integrated Cognitive Behavioral TherapyBEHAVIORAL

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

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • 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.

    PMID: 27574837DERIVED

MeSH Terms

Conditions

Chronic PainOpioid-Related Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Declan T. Barry, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 4, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

US(1)