Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Substance Abuse Clinical Trial

Official title:

Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988962
• Other study ID #: 2007p001732
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: June 22, 2011
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.

Description:

This study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic pain for >6 months

• history of taking daily opioids for pain for >6 months

• average >3 on a pain intensity scale of 0 to 10 over past week

• able to speak and understand English

• chronic neck or back pain as primary pain complaint

• willingness to participate

Exclusion Criteria:

• current opioid addiction (M.I.N.I. Section K)

• current diagnosis of cancer or any other malignant disease

• acute osteomyelitis or acute bone disease

• nonambulatory

• present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder

• pregnancy

• any clinically unstable systemic illness judged to interfere with treatment

• an acute condition requiring surgery

• taking opioids intermittently

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• cognitive behavioral training
electronic diaries, compliance checklists, urine screens, individual and group motivational counseling

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital Pain Management Center	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Akbik H, Butler SF, Budman SH, Fernandez K, Katz NP, Jamison RN. Validation and clinical application of the Screener and Opioid Assessment for Patients with Pain (SOAPP). J Pain Symptom Manage. 2006 Sep;32(3):287-93. — View Citation

Butler SF, Budman SH, Fernandez K, Jamison RN. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004 Nov;112(1-2):65-75. — View Citation

Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. Epub 2007 May 9. Erratum in: Pain. 2009 Mar;142(1-2):169. — View Citation

Butler SF, Fernandez K, Benoit C, Budman SH, Jamison RN. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008 Apr;9(4):360-72. doi: 10.1016/j.jpain.2007.11.014. Epub 2008 Jan 22. — View Citation

Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med. 2007 Oct;8 Suppl 3:S101-9. — View Citation

Michna E, Ross EL, Hynes WL, Nedeljkovic SS, Soumekh S, Janfaza D, Palombi D, Jamison RN. Predicting aberrant drug behavior in patients treated for chronic pain: importance of abuse history. J Pain Symptom Manage. 2004 Sep;28(3):250-8. — View Citation

Nedeljkovic SS, Wasan A, Jamison RN. Assessment of efficacy of long-term opioid therapy in pain patients with substance abuse potential. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S39-51. Review. — View Citation

Wasan AD, Butler SF, Budman SH, Fernandez K, Weiss RD, Greenfield SF, Jamison RN. Does report of craving opioid medication predict aberrant drug behavior among chronic pain patients? Clin J Pain. 2009 Mar-Apr;25(3):193-8. doi: 10.1097/AJP.0b013e318193a6c4. — View Citation

Wasan AD, Michna E, Janfaza D, Greenfield S, Teter CJ, Jamison RN. Interpreting urine drug tests: prevalence of morphine metabolism to hydromorphone in chronic pain patients treated with morphine. Pain Med. 2008 Oct;9(7):918-23. doi: 10.1111/j.1526-4637.2007.00354.x. Epub 2007 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens		All subjects will be followed for 6 months.	No
Secondary	1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings		Subjects will be followed for 6 months.	No