Chronic Pain, Problematic Opioid Use
Conditions
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.
Interventions
BEHAVIORALAcceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior | 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 | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU).
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention). | 17 |
| Treatment as Usual Physician directed care through a VA co-occurring disorders clinic that primarily provided medical oversight of opioid prescription and directed patients to other necessary pain interventions.
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention). | 18 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not begin intervention | 2 | 5 |
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Treatment as Usual | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 32 Participants | 16 Participants |
| Age, Continuous | 53.3 Years STANDARD_DEVIATION 8.6 | 50.5 Years STANDARD_DEVIATION 10.5 | 48.3 Years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 11 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 24 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 18 Participants | 11 Participants |
| Region of Enrollment United States | 18 participants | 35 participants | 17 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Current Opioid Misuse Measure (COMM)
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.
Time frame: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months
Population: Per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Current Opioid Misuse Measure (COMM) | Baseline | 16.2 units on a scale | Standard Deviation 8.8 |
| Intervention | Current Opioid Misuse Measure (COMM) | 6 month follow-up | 10.6 units on a scale | Standard Deviation 6.5 |
| Treatment as Usual | Current Opioid Misuse Measure (COMM) | Baseline | 17.4 units on a scale | Standard Deviation 7.8 |
| Treatment as Usual | Current Opioid Misuse Measure (COMM) | 6 month follow-up | 16.1 units on a scale | Standard Deviation 8.5 |
Primary
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior
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.
Time frame: 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).
Population: Per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior | Baseline | 66.7 units on a scale | Standard Deviation 6.6 |
| Intervention | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior | 6 month follow-up | 64.3 units on a scale | Standard Deviation 9.2 |
| Treatment as Usual | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior | Baseline | 66.0 units on a scale | Standard Deviation 6.6 |
| Treatment as Usual | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior | 6 month follow-up | 66.8 units on a scale | Standard Deviation 8 |
Primary
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
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.
Time frame: 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).
Population: Per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference | Baseline | 66.7 units on a scale | Standard Deviation 6.6 |
| Intervention | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference | 6 month follow-up | 64.3 units on a scale | Standard Deviation 9.2 |
| Treatment as Usual | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference | Baseline | 65.2 units on a scale | Standard Deviation 6.8 |
| Treatment as Usual | Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference | 6 month follow-up | 70.1 units on a scale | Standard Deviation 4.9 |