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Completed

NCT Number: NCT00249587

Medication Adherence Therapy for Opioid Abusing Pain Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Behavioral Science Research Unit

New York, 10025, United States

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Methadone

Drug

dosed to effect, every six hours

Primary outcomes

  1. Medication compliance and unauthorized drug use

    Time frame: 24 weeks

  2. Changes in pain severity and functioning

    Time frame: 24 weeks

Secondary outcomes

  1. Satisfaction with services

    Time frame: 12 weeks

  2. Therapeutic alliance

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Nov 7, 2005
Registry last updated
Jan 10, 2017

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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