Psychosocial Pain Management During Addictions Treatment to Improve Outcomes

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372267
• Other study ID #: 1R01DA029587-01A1
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: July 21, 2017
• Start date: October 2011
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: April 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Psychoeducation for substance abuse
This active control provides detailed educational information about substance use and chronic pain to those enrolled.
• 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.

Locations

Country	Name	City	State
United States	Community Programs, INC.	Waterford	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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