Medication Adherence Therapy for Opioid Abusing Pain Patients

Pain Clinical Trial

Official title:

Medication Adherence Therapy for Opioid Abusing Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249587
• Other study ID #: NIDA-13169-1
• Secondary ID: R01-13169-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 3, 2005
• Last updated: January 9, 2017
• Start date: September 2000
• Est. completion date: September 2005

Study information

• Verified date: September 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pain
• Prescription Opioid Abuse

Intervention

Drug:
• Methadone
dosed to effect, every six hours

Locations

Country	Name	City	State
United States	Behavioral Science Research Unit	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Haller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270

Paper presented at the American Academy of Addiction Psychiatry, December, 2004

Wunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication compliance and unauthorized drug use		24 weeks	No
Primary	Changes in pain severity and functioning		24 weeks	No
Secondary	Satisfaction with services		12 weeks	No
Secondary	Therapeutic alliance		12 weeks	No

External Links

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