Psychosocial Pain Management During Addictions Treatment to Improve Outcomes
|ClinicalTrials.gov Identifier: NCT01372267|
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : July 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Behavioral: Psychoeducation for substance abuse Behavioral: CBT for pain in Substance abuse||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||510 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||April 2017|
|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.
- 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
- 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
- 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
- Change in Substance use [ Time Frame: Baseline, three, six, twelve months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372267
|United States, Michigan|
|Community Programs, INC.|
|Waterford, Michigan, United States, 48327|