Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Psychosocial Pain Management During Addictions Treatment to Improve Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark A. Ilgen, University of Michigan
ClinicalTrials.gov Identifier:
NCT01372267
First received: June 7, 2011
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Pain
Behavioral: Psychoeducation for substance abuse
Behavioral: CBT for pain in Substance abuse

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in level of pain [ Time Frame: Baseline, one, three, six, twelve months ] [ Designated as safety issue: No ]
    For each follow-up time point, we will subtract the baseline value to obtain a change score

  • Change in pain tolerance [ Time Frame: Baseline, one, three, six, twelve months ] [ Designated as safety issue: No ]
    For each follow-up time point, we will subtract the baseline value to obtain a change score

  • Change in pain-related functioning [ Time Frame: Baseline, one, three, six, twelve months ] [ Designated as safety issue: No ]
    For each follow-up time point, we will subtract the baseline value to obtain a change score


Secondary Outcome Measures:
  • Change in Substance use [ Time Frame: Baseline, three, six, twelve months ] [ Designated as safety issue: No ]

Estimated Enrollment: 452
Study Start Date: October 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372267

Locations
United States, Michigan
Community Programs, INC.
Waterford, Michigan, United States, 48327
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Mark A. Ilgen, Associate Professor of Psychiatry, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT01372267     History of Changes
Other Study ID Numbers: 1R01DA029587-01A1
Study First Received: June 7, 2011
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Cognitive Behavioral Therapy
Chronic Pain
Substance Use Disorders
Psychoeducational control group

ClinicalTrials.gov processed this record on November 25, 2014