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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00988962

Enrollment

Registered

2009-10-02

Start date

2009-07-31

Completion date

2011-06-30

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse

Keywords

pain, opioids

Brief 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.

Detailed 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.

Interventions

BEHAVIORALcognitive behavioral training

electronic diaries, compliance checklists, urine screens, individual and group motivational counseling

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.

Secondary

Measure	Time frame
1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings	Subjects will be followed for 6 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026