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

November 3, 2005
September 19, 2008
September 2000
September 2005   (final data collection date for primary outcome measure)
  • 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 ]
  • Medication compliance and unauthorized drug use
  • Changes in pain severity and functioning
Complete list of historical versions of study NCT00249587 on ClinicalTrials.gov Archive Site
  • Satisfaction with services [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Therapeutic alliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Satisfaction with services
  • Therapeutic alliance
Not Provided
Not Provided
 
Medication Adherence Therapy for Opioid Abusing Pain Patients
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.

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 .

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Chronic Disease
  • Prescription Opioid Abuse
Drug: Methadone
dosed to effect, every six hours
  • Experimental: 1
    Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
    Intervention: Drug: Methadone
  • Active Comparator: 2
    Methadone plus behavioral counseling consisting of adherence
    Intervention: Drug: Methadone
Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2005
September 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00249587
NIDA-13169-1, R01-13169-1
No
Deborah Haller, Ph.D., St. Luke's-Roosevelt Hospital Center
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Deborah Haller St. Luke's Roosevelt Hosp Cntr (New York)
National Institute on Drug Abuse (NIDA)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP