Psychosocial Pain Management During Addictions Treatment to Improve Outcomes

July 21, 2017 updated by: Mark A. Ilgen, University of Michigan
The present intervention is a Stage II randomized controlled efficacy trial of a group-based intervention that integrates Cognitive Behavioral Therapy (CBT) for pain and substance use disorders (SUDs) compared to a Supportive Psychoeducation Control (SPC) group in a sample of patients receiving residential SUD treatment with co-occurring chronic pain. A total of 452 patients (226 male and 226 female) with current pain rated as moderately severe or greater and comorbid drug or alcohol use disorder(s) will be recruited from a large residential SUD treatment program. These participants will be randomly assigned to either a 4-week (8-session) group of integrated CBT for pain and SUDs or a 4-week (8-session) SPC group. All participants will be re-assessed immediately post-treatment (1 month) and again at 3, 6, and 12 months post-intervention. Through this randomized controlled trial, the investigators hope to gain insight on how to improved treatment of pain in those with SUDs that could result in enhanced quality of life and improved pain-related, substance use, and other health outcomes. Evaluating a psychosocial intervention for pain and substance use that can be delivered during a SUD treatment episode would significantly extend available treatment options for the large numbers of patients with pain seen by SUD treatment providers. The investigators also hope to determine the efficacy of an evidence-based psychosocial pain management approach in men and women from a large and diverse residential addiction treatment program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic pain among individuals who misuse drugs or alcohol is a common and critically important problem that is rarely managed appropriately. The estimated rates of chronic pain in Substance Use Disorder (SUD) treatment are as high as 60%. Chronic pain is seldom successfully addressed in SUD treatment settings because of a limited understanding of the problem and a lack of effective intervention strategies. A clear and urgent need exists for the study of effective alternatives to the use of opiate pain medications in those treated for SUDs who also have pain because of: (1) the potential for abuse and diversion of opiate medications by patients in SUD treatment; and (2) recent evidence that untreated pain may undermine the effectiveness of standard treatments for SUDs.

An important potential strategy to address this problem is the use of Cognitive Behavioral Therapy (CBT) to manage pain and decrease substance misuse. Psychosocial interventions such as CBT have demonstrated efficacy for reducing pain and improving functioning for a broad spectrum of pain-related conditions. However, this form of treatment has not been explicitly tested in patients with co-occurring substance use disorders. Additionally, although pain is common in both men and women, most studies have lacked sufficient power to test the effect of interventions separately in men and women. The present intervention is designed to integrate CBT for pain and CBT for SUDs with the primary goal of improving pain- and substance-related outcomes. The investigators will test the efficacy of this modified protocol on both men and women in this understudied patient population.

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Waterford, Michigan, United States, 48327
        • Community Programs, INC.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be over 18 years of age
  • Report moderate to severe pain over past 3 months
  • Resided in treatment for less than 60 days

Exclusion Criteria:

  • Acute suicidality
  • Mental incompetence (e.g. unable to provide informed consent)
  • Evidence of current psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT for pain
Behavioral: CBT for pain in Substance abuse
The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and pain.
Active Comparator: Psychoeducational control group
This group is designed to be an active control which provides detailed information about substance us and chronic pain without providing any CBT or other specific therapy.
Behavioral: Psychoeducation for substance abuse
This active control provides detailed educational information about substance use and chronic pain to those enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in level of pain
Time Frame: Baseline, one, three, six, twelve months
For each follow-up time point, we will subtract the baseline value to obtain a change score
Baseline, one, three, six, twelve months
Change in pain tolerance
Time Frame: Baseline, one, three, six, twelve months
For each follow-up time point, we will subtract the baseline value to obtain a change score
Baseline, one, three, six, twelve months
Change in pain-related functioning
Time Frame: Baseline, one, three, six, twelve months
For each follow-up time point, we will subtract the baseline value to obtain a change score
Baseline, one, three, six, twelve months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Substance use
Time Frame: Baseline, three, six, twelve months
Baseline, three, six, twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (Estimate)

June 13, 2011

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01DA029587-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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