Medication Adherence Therapy for Opioid Abusing Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249587
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 10, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Pain Chronic Disease Prescription Opioid Abuse Drug: Methadone Phase 1 Phase 2

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 .

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medication Adherence Therapy for Opioid Abusing Pain Patients
Study Start Date : September 2000
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Medication compliance and unauthorized drug use [ Time Frame: 24 weeks ]
  2. Changes in pain severity and functioning [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Satisfaction with services [ Time Frame: 12 weeks ]
  2. Therapeutic alliance [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249587

United States, New York
Behavioral Science Research Unit
New York, New York, United States, 10025
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Deborah Haller St. Luke's Roosevelt Hosp Cntr (New York)

Haller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270
Wunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747
Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197
Paper presented at the American Academy of Addiction Psychiatry, December, 2004

Responsible Party: Deborah Haller, Ph.D., St. Luke's-Roosevelt Hospital Center Identifier: NCT00249587     History of Changes
Other Study ID Numbers: NIDA-13169-1
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: September 2008

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