Medication Adherence Therapy for Opioid Abusing Pain Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00249587
First received: November 3, 2005
Last updated: September 19, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Pain
Chronic Disease
Prescription Opioid Abuse
Drug: Methadone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medication Adherence Therapy for Opioid Abusing Pain Patients

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Medication compliance and unauthorized drug use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in pain severity and functioning [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction with services [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Therapeutic alliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2000
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249587

Locations
United States, New York
Behavioral Science Research Unit
New York, New York, United States, 10025
Sponsors and Collaborators
Investigators
Principal Investigator: Deborah Haller St. Luke's Roosevelt Hosp Cntr (New York)
  More Information

Additional Information:
Publications:
Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197

Responsible Party: Deborah Haller, Ph.D., St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00249587     History of Changes
Other Study ID Numbers: NIDA-13169-1, R01-13169-1
Study First Received: November 3, 2005
Last Updated: September 19, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 19, 2014