This trial is active, not recruiting.

Condition pain
Treatments psychoeducation for substance abuse, cbt for pain in substance abuse
Sponsor University of Michigan
Collaborator National Institute on Drug Abuse (NIDA)
Start date October 2011
End date January 2016
Trial size 452 participants
Trial identifier NCT01372267, 1R01DA029587-01A1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
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)
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.
psychoeducation for substance abuse
This active control provides detailed educational information about substance use and chronic pain to those enrolled.

Primary Outcomes

Change in level of pain
time frame: Baseline, one, three, six, twelve months
Change in pain tolerance
time frame: Baseline, one, three, six, twelve months
Change in pain-related functioning
time frame: Baseline, one, three, six, twelve months

Secondary Outcomes

Change in Substance use
time frame: Baseline, three, six, twelve months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Michigan.