Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Waterford, Michigan 48327


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.


Study summary:

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.


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


Study is Available At:


Original ID:

1R01DA029587-01A1


NCT ID:

NCT01372267


Secondary ID:


Study Acronym:


Brief Title:

Psychosocial Pain Management During Addictions Treatment to Improve Outcomes


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

510


Enrollment Type:

Actual


Study Dates

Start Date:October 2011
Completion Date:April 2017
Completion Type:Actual
Primary Completion Date:January 2016
Primary Completion Type:Actual
Verification Date:July 2017
Last Changed Date:July 21, 2017
First Received Date:June 7, 2011

Study Outcomes

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

Study Interventions

Intervention Type:Behavioral
Name:CBT for pain in Substance abuse
Description:The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and pain.
Arm Name:CBT for pain
Intervention Type:Behavioral
Name:Psychoeducation for substance abuse
Description:This active control provides detailed educational information about substance use and chronic pain to those enrolled.
Arm Name:Psychoeducational control group

Study Arms

Study Arm Type:Active Comparator
Arm Name:Psychoeducational control group
Description: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.
Study Arm Type:Experimental
Arm Name:CBT for pain

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.