Medication Adherence Therapy for Opioid Abusing Pain Patients

January 9, 2017 updated by: National Institute on Drug Abuse (NIDA)
The purpose of this study is to develop and pilot test a combined behavioral and pharmacological intervention designed to decrease pain, functional interference, and drug abuse while increasing medication adherence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Project Pain is a Stage I behavioral therapies development project aimed at developing and pilot testing a novel intervention for patients with chronic non-malignant pain who have experienced difficulty managing prescribed opioids. The goals of the study are to: (1) develop the intervention and training materials; (2) develop therapist adherence and competence scales; (3) train therapists to deliver the intervention per the treatment protocol; and (4) pilot the intervention to assess its feasibility, acceptability and promise. The goals of the intervention are to: (1) improve adherence to prescribed opioids; (2) decrease the severity of patients' pain; and (3) improve patients' functioning and quality of life .

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • Behavioral Science Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Uninterrupted pain of at least 6 months duration
  • Pain is continuous, rather than intermittent
  • Pain in the severe range (VAS = 7-10) while medicated
  • Poor response to non-pharmacological interventions for pain (if appropriate)
  • One or more of the following pain diagnoses: (a) back/neck pain; (b) myofacial pain; (c) neuropathic pain (e.g., diabetic or AIDS neuropathy, Complex regional pain syndrome); (d) arthritic pain; (e) MS; or (f) sickle cell (must meet chronicity criteria)
  • Evidence of tolerance/physiological dependence on opioid analgesics
  • Current opioid use disorder (DSM-IV criteria)
  • Continuous use of opioid analgesics for a minimum of 6 months prior to referral. [Note: This is consistent with minimum 6-month requirement for diagnosis of chronic pain].
  • Minimum of 2 signs/symptoms of medication mismanagement identified by the Referring MD (PROBLEMS WITH PAIN MEDS checklist)

Exclusion Criteria:

  • Please contact site regarding exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
Drug: Methadone
dosed to effect, every six hours
Active Comparator: 2
Methadone plus behavioral counseling consisting of adherence
Drug: Methadone
dosed to effect, every six hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication compliance and unauthorized drug use
Time Frame: 24 weeks
24 weeks
Changes in pain severity and functioning
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfaction with services
Time Frame: 12 weeks
12 weeks
Therapeutic alliance
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Deborah Haller, St. Luke's Roosevelt Hosp Cntr (New York)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Haller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270
  • Wunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747
  • Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197
  • Paper presented at the American Academy of Addiction Psychiatry, December, 2004

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-13169-1
  • R01-13169-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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