Medication Adherence Therapy for Opioid Abusing Pain Patients

NCT00249587 | Completed Phase 1

• 2 other identifiers: NIDA-13169-1R01-13169-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Chronic Disease; Prescription Opioid Abuse

Outcome Measures

Primary Outcomes (2)

• Medication compliance and unauthorized drug use

  24 weeks

• Changes in pain severity and functioning

  24 weeks

Secondary Outcomes (2)

• Satisfaction with services

  12 weeks

• Therapeutic alliance

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing

Drug: Methadone

2

ACTIVE COMPARATOR

Methadone plus behavioral counseling consisting of adherence

Drug: Methadone

Interventions

Methadone DRUG

dosed to effect, every six hours

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Behavioral Science Research Unit

New York, New York, 10025, United States

Location

Related Publications (4)

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Pain; Chronic Disease; Opioid-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Deborah Haller

  St. Luke's Roosevelt Hosp Cntr (New York)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 7, 2005
• Study Start: September 1, 2000
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: January 10, 2017

Record last verified: 2008-09

Locations

US (1)