Chronic Pain, Opioid Abuse, Unspecified Use
Conditions
Brief summary
Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.
Detailed description
Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.
Interventions
MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.
BEHAVIORALConventional Support Group (SG)
The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions.
Sponsors
National Institute on Drug Abuse (NIDA)
Fahs Beck Fund for Research and Experimentation
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic pain diagnosis (ICD-9 diagnoses 338.xx) * treatment with prescription opioids for \> 3 months
Exclusion criteria
* prior mindfulness training * persons who are experiencing acute opioid withdrawal * suicidal ideation * psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity, pain functional interference | Baseline, immediately following treatment, and at 3 month follow-up | Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form. |
| Opioid craving | Baseline, immediately following treatment, and at 3 month follow-up | Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving. |
| Opioid misuse behaviors | Baseline, immediately following treatment, and at 3 month follow-up | Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure |
| Well-being | Baseline, immediately following treatment, and at 3 month follow-up | Change in well-being as measured by the WHO-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anhedonia | Baseline and immediately following treatment | Change in anhedonia |
| Fear of pain | Baseline and immediately following treatment | Change in fear of pain |
| Attentional bias | Baseline and immediately following treatment | Change in attentional bias as measured by a dot probe task |
| Positive reappraisal | Baseline and immediately following treatment | Change in positive reappraisal |
| Mindfulness | Baseline, intervention midpoint, and immediately following treatment | Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale |
| Psychophysiological cue-reactivity | Baseline and immediately following treatment | Change in psychophysiological cue-reactivity |
| Emotional response inhibition | Baseline and immediately following treatment | Change in emotional response inhibition |
| Pain coping strategies | Baseline, intervention midpoint, and immediately following treatment | Change in reinterpretation of pain sensations, catastrophizing, and suppression. |
Countries
United States
Outcome results
None listed