Managing Chronic Pain in Veterans With Substance Use Disorders

NCT ID: NCT00982410

Last Updated: 2015-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-03-31

Brief Summary

The proposed project will provide crucial data on the effectiveness of a pain management intervention designed for veterans with co-occurring pain and substance use disorders. The development of an empirically validated psychosocial intervention for managing pain and substance misuse could greatly enhance the current set of options for treating this large and understudied group of veterans.

Detailed Description

Background: Chronic non-cancer pain and substance use disorders frequently co-occur in VA primary care and addictions treatment settings. The treatment for pain is complicated in veterans with a history of alcohol or drug misuse because of a potential for abuse and diversion of many prescription pain medications. Thus, treatment providers are left without successful and empirically-supported methods for treating the large number of patients with chronic pain who also have past or current substance use disorders. One potential strategy is to use cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse. Psychosocial interventions such as CBT have demonstrated efficacy for reducing pain and improving functioning in persons with a broad spectrum of pain-related problems. However, this form of treatment has not been explicitly tested in patients with co-occurring substance use disorders. Determining the effectiveness of a psychosocial intervention targeting both pain and substance use disorders would greatly increase the available treatment options for veterans with these conditions.

Project Objectives: This project is designed to test the effect of a CBT intervention for patients with chronic pain who are already engaged in VA treatment for substance use disorders compared to an educational supportive condition on measures of pain intensity, pain-related disability and pain-tolerance. A set of secondary analyses will examine if group CBT compared to the educational supportive condition is associated with greater reductions in illicit substance use over the follow-up time period and whether during-treatment reductions in pain mediate the effect of treatment assignment on later substance use. Finally, a series of secondary analyses will explore whether the hypothesized mechanisms of action for the CBT intervention mediate the effect of this intervention on pain intensity and pain tolerance.

Methods: The proposed study is a randomized controlled trial of group-based CBT compared to an educational supportive condition in patients currently receiving drug and alcohol treatment. At least 128 Veterans with alcohol or drug abuse or dependence and at least moderate pain currently treated in the Ann Arbor VA Substance Use Disorder treatment clinic will be assessed at baseline and then randomly assigned to one of these two conditions. These patients will be re-assessed at 3-months (i.e. immediately post treatment), 6-months and 12-months. The primary outcomes will be pain intensity, pain-related disability and pain tolerance. Mixed model regression analyses will be used for all primary analyses to estimate between-group differences in changes in individual slopes over time. Finally, a series of secondary analyses will explore (a) whether the intervention influences post-treatment substance use, (b) if change in pain during treatment mediates the effect of the intervention on subsequent substance use and (c) whether the hypothesized mechanisms of action for the CBT intervention mediate the effect of this intervention on pain intensity and pain tolerance.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse

Group Type: EXPERIMENTAL

cognitive-behavioral treatment

Intervention Type: BEHAVIORAL

cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse

Arm 2

educational supportive group

Group Type: PLACEBO_COMPARATOR

educational supportive group

Intervention Type: BEHAVIORAL

A control condition providing social support and education about pain and/or drug use.

Interventions

cognitive-behavioral treatment

cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse

Intervention Type: BEHAVIORAL

educational supportive group

A control condition providing social support and education about pain and/or drug use.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A report of pain of at least moderate or greater over the three months prior to baseline assessment as indicated by an average score of four or greater on the Numeric Rating Scale of pain intensity (NRS-I; Farrar et al. 2001);
• Completion of an intake assessment in the Ann Arbor VA's SUD clinic within the three months prior to baseline assessment. The pain-related inclusion criterion will be used to ensure that participants are experiencing elevated levels of pain and, consequently, are appropriate for pain-related treatment.

Exclusion Criteria

• Acute suicidality based on responses on the Beck Depression Inventory (BDI) confirmed by in-depth assessment of patient by the research associate;
• Psychiatric condition that precludes participation in outpatient group treatment based on:

• a Mini-Mental State Examination (MMSE; Folstein et al. 1975) score less than 21,
• psychiatric hospitalization within the past month, or
• endorsement of current psychotic symptoms on the Brief Symptom Inventory (BSI; Derogatis 1993) combined with noticeable bizarre thoughts or behavior during the interview;
• Inability to speak and understand English; and
• The inability to give informed, voluntary, written consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A. Ilgen, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System

Locations

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

IAC 09-047

Identifier Type: -

Identifier Source: org_study_id