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Clinical Trial of Integrated Treatment for Pain and Opioid Dependence

Conditions

Chronic Pain | Opiate Dependence

Trial Phase

Phase 1/Phase 2

Trial Purpose and Description

Trial Purpose

This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.


Trial Description

This study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (POD).

Specific Aims:

  1. To conduct a pre-pilot phase with 16 patients with POD receiving buprenorphine maintenance treatment (BMT). In the pre-pilot phase, we will also explore the effects of different daily buprenorphine dosages on pain and opiate use.
  2. To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to Physician Management(PM) only) of manual-guided CBT or Educational Counseling (EC) for patients with POD treated with BMT (N=75).

Participation Guidelines

Age:
18 Years - 65 Years
Gender:
Both

Eligibility Criteria


Inclusion Criteria:

- 18 years of age or older

- prescription opioid addiction criteria

- moderate to severe chronic pain

- seeking or interested in buprenorphine maintenance

- understand English

Exclusion Criteria:

- methadone maintenance at a dose greater than 40 mg daily

- current suicide or homicide risk

- life-threatening or unstable medical problem

- pregnancy
Sponsor:
Yale University
Dates:
September 2009
Last Updated:
May 16, 2012
Study HIC#:
0608001776

Clinicaltrials.gov ID: NCT00634803