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NCT Number: NCT01372267

Psychosocial Pain Management During Addictions Treatment to Improve Outcomes

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.

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Key information

Conditions

Pain Chemically-Induced Disorders Chronic Pain Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Programs, INC.

Waterford, Michigan, 48327, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation for substance abuse

Behavioral

This active control provides detailed educational information about substance use and chronic pain to those enrolled.

CBT for pain in Substance abuse

Behavioral

The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and pain.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Change in Substance use

    Time frame: Baseline, three, six, twelve months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jun 13, 2011
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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