Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse

NCT ID: NCT02423772

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-07-31

Brief Summary

Chronic pain and misuse of opioids is a major public health problem, particularly in military veterans. The major goal of this project is to test the efficacy of an innovative behavioral treatment for chronic pain patients who are misusing prescription opiates. This project supports the strategic goals of National Center for Complementary and Integrative Health (NCCIH) and National Institute on Drug Abuse by examining a difficult and understudied problem with the ultimate goal of impacting scientific knowledge and human health.

Detailed Description

Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for opioid dependence. Despite the alarming increases (140% increase from 1992 to 2003) in prescription opiate misuse, abuse, and dependence nationally in the United States, there are few treatment options available that target both pain-related interference and opioid dependence among patients with chronic pain. In military veterans, this issue is of particular importance as numerous reports indicate increasing use of opioids in the treatment of chronic pain, as well as increasing opioid-related problems, specifically in those who served in the Iraq and Afghanistan theatres [Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND)]. To date, there are no evidenced-based treatment options which aim to both maximize effective functioning in Veterans with chronic pain while simultaneously addressing problematic opioid use. The overall aim of the present study will be to determine the feasibility of an integrated psychosocial treatment in veterans with chronic pain, who also have evidence of opioid-related misuse. To examine this aim, the investigators will utilize a randomized design to assess the feasibility of integrating two empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness Based Relapse Prevention for substance use and misuse. Feasibility will be assessed by examining rates of recruitment and retention of participants through a six month follow-up. In addition, the investigators will evaluate progress within-treatment on specific therapy targets to aid in the identification of potential treatment mechanisms. The results of this study will directly inform treatment of chronic pain patients and represents a significant advance in the growing and understudied problem of opiate misuse among chronic pain patients. In addition to addressing the question of whether the treatment is feasible, it will further examine issues of treatment mechanisms to better inform the design of a randomized and controlled trial assessing treatment efficacy.

Conditions

Chronic Pain; Problematic Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 21-65 years old
• Diagnosis of chronic pain condition
• Pain severity over the past seven days of four or greater on a 0-10 scale
• Prescribed opioids for the treatment of chronic pain for the past 90 days or longer
• Ability to read written English

Exclusion Criteria

• Meet diagnostic criteria for current substance abuse/dependence on a drug other than opioids
• Meet diagnostic criteria for a current or past DSM diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders,
• Currently prescribed medications for opioid addiction (e.g., Buprenorphine/Naloxone/Suboxone).
• History of suicide attempts or inpatient hospitalization for risk of suicide in the past six month. In addition, we will screen for significant suicidal

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Raymond G. Murphy VA Medical Center

Albuquerque, New Mexico, United States

Countries

United States

References

Pielech M, Kruger E, Rivers WE, Snow HE, Vowles KE. Receipt of multiple outpatient opioid prescriptions is associated with increased risk of adverse outcomes in youth: opioid prescribing trends, individual characteristics, and outcomes from 2005 to 2016. Pain. 2020 Jun;161(6):1297-1310. doi: 10.1097/j.pain.0000000000001812.

Reference Type: BACKGROUND

PMID: 31977934 (View on PubMed)

Witkiewitz K, Votaw VR, Vowles KE, Kranzler HR. Opioid Misuse as a Predictor of Alcohol Treatment Outcomes in the COMBINE Study: Mediation by Medication Adherence. Alcohol Clin Exp Res. 2018 Jul;42(7):1249-1259. doi: 10.1111/acer.13772. Epub 2018 Jun 9.

Reference Type: BACKGROUND

PMID: 29873089 (View on PubMed)

Vowles KE, Bailey RW, McEntee ML, Pielech M, Edwards KA, Bolling LA, Rivers WE. Using Analgesics for Emotional Modulation is Associated With Increased Distress, Depression, and Risk of Opioid and Alcohol Misuse: Initial Evaluation and Component Analysis of the Reasons for Analgesic Use Measure (RAUM). Clin J Pain. 2018 Oct;34(10):975-982. doi: 10.1097/AJP.0000000000000621.

Reference Type: BACKGROUND

PMID: 29697475 (View on PubMed)

Witkiewitz K, Vowles KE. Alcohol and Opioid Use, Co-Use, and Chronic Pain in the Context of the Opioid Epidemic: A Critical Review. Alcohol Clin Exp Res. 2018 Mar;42(3):478-488. doi: 10.1111/acer.13594. Epub 2018 Feb 6.

Reference Type: BACKGROUND

PMID: 29314075 (View on PubMed)

Bailey RW, Vowles KE. Using Screening Tests to Predict Aberrant Use of Opioids in Chronic Pain Patients: Caveat Emptor. J Pain. 2017 Dec;18(12):1427-1436. doi: 10.1016/j.jpain.2017.06.004. Epub 2017 Jun 29.

Reference Type: BACKGROUND

PMID: 28669863 (View on PubMed)

Pielech M, Vowles KE, Wicksell R. Acceptance and Commitment Therapy for Pediatric Chronic Pain: Theory and Application. Children (Basel). 2017 Jan 30;4(2):10. doi: 10.3390/children4020010.

Reference Type: BACKGROUND

PMID: 28146108 (View on PubMed)

Witkiewitz K, McCallion E, Vowles KE, Kirouac M, Frohe T, Maisto SA, Hodgson R, Heather N. Association between physical pain and alcohol treatment outcomes: The mediating role of negative affect. J Consult Clin Psychol. 2015 Dec;83(6):1044-57. doi: 10.1037/ccp0000033. Epub 2015 Jun 22.

Reference Type: BACKGROUND

PMID: 26098375 (View on PubMed)

Witkiewitz K, Vowles KE, McCallion E, Frohe T, Kirouac M, Maisto SA. Pain as a predictor of heavy drinking and any drinking lapses in the COMBINE study and the UK Alcohol Treatment Trial. Addiction. 2015 Aug;110(8):1262-71. doi: 10.1111/add.12964. Epub 2015 Jun 3.

Reference Type: BACKGROUND

PMID: 25919978 (View on PubMed)

Vowles KE, Witkiewitz K, Cusack KJ, Gilliam WP, Cardon KE, Bowen S, Edwards KA, McEntee ML, Bailey RW. Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. J Pain. 2020 Jul-Aug;21(7-8):798-807. doi: 10.1016/j.jpain.2019.11.007. Epub 2019 Nov 21.

Reference Type: RESULT

PMID: 31760109 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AT008398-01

Identifier Type: -

Identifier Source: org_study_id