Early Phase 1
N=131
Managing Chronic Pain in Veterans With Substance Use Disorders
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00982410 ↗Enrolled (actual)
131
Serious AEs
2.3%
Results posted
Dec 2014
Primary outcome: Primary: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1) — 5.82; 6.47 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- cognitive-behavioral treatment (Behavioral); educational supportive group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1) |
5.82; 6.47 | <0.05 sig |
| PRIMARY The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI) |
2.24; 2.00 | <0.05 sig |
| PRIMARY Alcohol Use |
2.05; 4.04 | <0.01 sig |
| PRIMARY Drug Use |
6.82; 6.85 | >0.05 |
| PRIMARY Pain Tolerance |
70.2; 65.5 | >0.05 |
| SECONDARY Self-efficacy of Pain Management |
57.9; 47.59 | <0.005 sig |
| SECONDARY Self-efficacy of Physical Functioning |
69.12; 61.57 | — |
| SECONDARY As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1) |
5.84; 6.47 | — |
| SECONDARY As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI) |
2.22; 1.95 | — |
Summary
The proposed project will provide crucial data on the effectiveness of a pain management intervention designed for veterans with co-occurring pain and substance use disorders. The development of an empirically validated psychosocial intervention for managing pain and substance misuse could greatly enhance the current set of options for treating this large and understudied group of veterans.
Eligibility Criteria
Inclusion Criteria
- A report of pain of at least moderate or greater over the three months prior to baseline assessment as indicated by an average score of four or greater on the Numeric Rating Scale of pain intensity (NRS-I; Farrar et al. 2001);
- Completion of an intake assessment in the Ann Arbor VA's SUD clinic within the three months prior to baseline assessment. The pain-related inclusion criterion will be used to ensure that participants are experiencing elevated levels of pain and, consequently, are appropriate for pain-related treatment.
Exclusion Criteria
- Acute suicidality based on responses on the Beck Depression Inventory (BDI) confirmed by in-depth assessment of patient by the research associate;
- Psychiatric condition that precludes participation in outpatient group treatment based on:
- a Mini-Mental State Examination (MMSE; Folstein et al. 1975) score less than 21,
- psychiatric hospitalization within the past month, or
- endorsement of current psychotic symptoms on the Brief Symptom Inventory (BSI; Derogatis 1993) combined with noticeable bizarre thoughts or behavior during the interview;
- Inability to speak and understand English; and
- The inability to give informed, voluntary, written consent.
Decisions about exclusion criteria 1 and 2 will be made using a combination of self-reported symptoms and researcher's judgment.
Data sourced from ClinicalTrials.gov (NCT00982410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.