Clinical trial NCT00982410: Managing Chronic Pain in Veterans With Substance Use Disorders
Official title: Managing Chronic Pain in Veterans With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Pain
Keywords: pain
alcohol
illicit drugs
pain management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-09-23
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Decisions about exclusion criteria 1 and 2 will be made using a combination of self-reported symptoms and researcher's judgment.

Primary outcomes:
measure: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)
timeFrame: Baseline, 3-, 6-, & 12-months
measure: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)
timeFrame: Baseline, 3-,6-, 12-month
measure: Alcohol Use
timeFrame: Baseline, 3-, 6-, 12- months
measure: Drug Use
timeFrame: Baseline, 3-, 6-, 12- months
measure: Pain Tolerance
timeFrame: Baseline, 3-,6-,12-months
Secondary outcomes:
measure: Self-efficacy of Pain Management
timeFrame: Baseline, 3-, 6-, 12- months
measure: Self-efficacy of Physical Functioning
timeFrame: Baseline, 3-, 6-, 12- months
measure: As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)
timeFrame: Baseline, 3-, 6-, 12-months
measure: As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)
timeFrame: Baseline, 3mo, 6mo, 12mo follow-up
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System
name: Mark A. Ilgen, PhD
role: PRINCIPAL_INVESTIGATOR
References: