Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
干预措施: Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU) (Behavioral)
Treatment as Usual
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior
时间窗: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months post end of intervention period).
The PROMIS pain behavior (PROMIS short form v1.1 7a) measures self-reported frequency of verbal and nonverbal behaviors indicating that one is experiencing pain. It consists of 7 items with scores ranging from 7 to 35 with higher scores indicating more frequent pain behavior.
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
时间窗: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months post end of intervention period).
The PROMIS pain interference Short Form 8a assesses the impact of pain on important aspects of social, physical, cognitive, and recreational activities. It consists of 8 items and scores range from 8 to 40 with higher scores indicating greater pain interference.
Current Opioid Misuse Measure (COMM)
时间窗: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months
Total Score of the COMM was used. The COMM is a 17-item measure designed to aid in the identification of opioid misuse. Scores range from 0 to 68 with higher scores indicating greater risk of misuse.
次要结局
未报告次要终点