Clinical trial NCT00249587: Medication Adherence Therapy for Opioid Abusing Pain Patients
Official title: Medication Adherence Therapy for Opioid Abusing Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain
Chronic Disease
Prescription Opioid Abuse
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Medication compliance and unauthorized drug use
timeFrame: 24 weeks
measure: Changes in pain severity and functioning
timeFrame: 24 weeks
Secondary outcomes:
measure: Satisfaction with services
timeFrame: 12 weeks
measure: Therapeutic alliance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Behavioral Science Research Unit
state: New York
Study officials:
affiliation: St. Luke's Roosevelt Hosp Cntr (New York)
name: Deborah Haller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270
citation: Wunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747
citation: Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197
citation: Paper presented at the American Academy of Addiction Psychiatry, December, 2004