Managing Chronic Pain in Veterans With Substance Use Disorders

NCT00982410 | Completed Early Phase 1 Results

• 1 other identifier: IAC 09-047
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

pain; alcohol; illicit drugs; pain management

Outcome Measures

Primary Outcomes (5)

• Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)

  The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period. Average pain in the last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation.

  Baseline, 3-, 6-, & 12-months

• The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)

  The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. Aspects include ability to perform chores inside the home, activities away from the home, and social functioning. The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period, and was adjusted for baseline WHY MPI General Activity score.

  Baseline, 3-,6-, 12-month

• Alcohol Use

  #days used alcohol in the past 30 days, as assessed via timeline follow-back(TLFB) calendars. #days in a controlled environment (e.g. hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days alcohol use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used alcohol.

  Baseline, 3-, 6-, 12- months

• Drug Use

  \# days used illicit drugs in the past 30 days, as assessed via timeline follow-back (TLFB) calendars. Use of illicit drugs and misuse of prescription drugs (e.g., Rx opioids) were recorded for the 30 days prior to the follow-up visit. #days in a controlled environment (e.g., hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days drug use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used illicit drugs.

  Baseline, 3-, 6-, 12- months

• Pain Tolerance

  Pain tolerance was measured by the amount of time the participant could hold their hand immersed in a vessel of cold water in seconds. The maximum allowed duration of the test was two minutes. The outcome measure below represents the average duration of task in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of pain tolerance.

  Baseline, 3-,6-,12-months

Secondary Outcomes (4)

• Self-efficacy of Pain Management

  Baseline, 3-, 6-, 12- months

• Self-efficacy of Physical Functioning

  Baseline, 3-, 6-, 12- months

• As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)

  Baseline, 3-, 6-, 12-months

• As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)

  Baseline, 3mo, 6mo, 12mo follow-up

Study Arms (2)

Arm 1

EXPERIMENTAL

cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse

Behavioral: cognitive-behavioral treatment

Arm 2

PLACEBO COMPARATOR

educational supportive group

Behavioral: educational supportive group

Interventions

cognitive-behavioral treatment BEHAVIORAL

cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse

Arm 1

educational supportive group BEHAVIORAL

A control condition providing social support and education about pain and/or drug use.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113-0170, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain; Substance-Related Disorders; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Dr. Mark Ilgen
• Organization: Ann Arbor Veteran Affairs

Mark.Ilgen@va.gov

(734) 845-3646

Study Officials

• Mark A. Ilgen, PhD

  VA Ann Arbor Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 23, 2009
• Study Start: April 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 13, 2015
• Results First Posted: December 24, 2014

Record last verified: 2015-06

Locations

US (1)