Chronic PainEarly Phase 1NCT00982410
Managing Chronic Pain in Veterans With Substance Use Disorders
A Early Phase 1 study testing cognitive-behavioral treatment and educational supportive group in people with Chronic Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- cognitive-behavioral treatment and educational supportive group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2014
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113-0170
About this study
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.
Read the detailed description
Background: Chronic non-cancer pain and substance use disorders frequently co-occur in VA primary care and addictions treatment settings. The treatment for pain is complicated in veterans with a history of alcohol or drug misuse because of a potential for abuse and diversion of many prescription pain medications. Thus, treatment providers are left without successful and empirically-supported methods for treating the large number of patients with chronic pain who also have past or current substance use disorders. One potential strategy is to use cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse. Psychosocial interventions such as CBT have demonstrated efficacy for reducing pain and improving functioning in persons with a broad spectrum of pain-related problems. However, this form of treatment has not been explicitly tested in patients with co-occurring substance use disorders. Determining the effectiveness of a psychosocial intervention targeting both pain and substance use disorders would greatly increase the available treatment options for veterans with these conditions.
Project Objectives: This project is designed to test the effect of a CBT intervention for patients with chronic pain who are already engaged in VA treatment for substance use disorders compared to an educational supportive condition on measures of pain intensity, pain-related disability and pain-tolerance. A set of secondary analyses will examine if group CBT compared to the educational supportive condition is associated with greater reductions in illicit substance use over the follow-up time period and whether during-treatment reductions in pain mediate the effect of treatment assignment on later substance use. Finally, a series of secondary analyses will explore whether the hypothesized mechanisms of action for the CBT intervention mediate the effect of this intervention on pain intensity and pain tolerance.
Methods: The proposed study is a randomized controlled trial of group-based CBT compared to an educational supportive condition in patients currently receiving drug and alcohol treatment. At least 128 Veterans with alcohol or drug abuse or dependence and at least moderate pain currently treated in the Ann Arbor VA Substance Use Disorder treatment clinic will be assessed at baseline and then randomly assigned to one of these two conditions. These patients will be re-assessed at 3-months (i.e. immediately post treatment), 6-months and 12-months. The primary outcomes will be pain intensity, pain-related disability and pain tolerance. Mixed model regression analyses will be used for all primary analyses to estimate between-group differences in changes in individual slopes over time. Finally, a series of secondary analyses will explore (a) whether the intervention influences post-treatment substance use, (b) if change in pain during treatment mediates the effect of the intervention on subsequent substance use and (c) whether the hypothesized mechanisms of action for the CBT intervention mediate the effect of this intervention on pain intensity and pain tolerance.
- Conditions
- Chronic Pain
- Being tested
- cognitive-behavioral treatment, educational supportive group
- Keywords
- pain, alcohol, illicit drugs, pain management
- Medical subject headings
- Chronic Pain, Pain, Substance-Related Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavioral treatmentBehavioural
cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse
educational supportive groupBehavioural
A control condition providing social support and education about pain and/or drug use.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse Receives: Behavioral: cognitive-behavioral treatment |
| Arm 2 | Placebo comparator | educational supportive group Receives: Behavioral: educational supportive group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3-,6-,12-months
Secondary outcomes (4)
Self-efficacy of Pain Management
As measured via CPSS PSE score at each time point. The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS PSE subscale is a measure of self-efficacy for pain management. These scales have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS PSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline CPSS PSE.
Measured: Baseline, 3-, 6-, 12- months
Self-efficacy of Physical Functioning
The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS subscale, self-efficacy for physical function (FSE), utilized to assess management of pain-related disability, with respect to several aspects of daily functioning. This scale have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS FSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of CPSS FSE.
Measured: Baseline, 3-, 6-, 12- months
As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)
Per study protocol, participants were asked to attend 10 sessions, which comprised the intervention for CBT participants and educational support for EUC participants. Some participants in each group did not attend any sessions, yet participated in follow-up assessments. The As-treated analysis was undertaken to evaluate the impact of the intervention, among participants that attended at least 1 session. As in the Primary Analysis, average pain 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
Measured: Baseline, 3-, 6-, 12-months
As-treated Analysis: 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. The outcome measure below represents the average WHY MPI General Activity score in each Arm/Group, across the entire follow-up period, adjusted for baseline WHY MPI General Activity score, but restricted here to study participants that partook in at least one treatment group session.
Measured: Baseline, 3mo, 6mo, 12mo follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startApr 2010
- Primary completionAug 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mark A. Ilgen, PhD, Principal investigator, VA Ann Arbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982410
- Sponsor's protocol ID
- IAC 09-047
- Status last verified
- Jun 2015
- First submitted
- 21 Sep 2009
- Last updated
- 13 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Chronic Pain in Veterans With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT00982410
- Acronym / sponsor ID
- IAC 09-047
- Conditions
- Chronic Pain
- Keywords
- pain, alcohol, illicit drugs, pain management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Posted 24 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Chronic non-cancer pain and substance use disorders frequently co-occur in VA primary care and addictions treatment settings. The treatment for pain is complicated in veterans with a history of alcohol or drug misuse because of a potential for abuse and diversion of many prescription pain medications. Thus, treatment providers are left without successful and empirically-supported methods for treating the large number of patients with chronic pain who also have past or current substance use disorders. One potential strategy is to use cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse. Psychosocial interventions such as CBT have demonstrated efficacy for reducing pain and improving functioning in persons with a broad spectrum of pain-related problems. However, this form of treatment has not been explicitly tested in patients with co-occurring substance use disorders. Determining the effectiveness of a psychosocial intervention targeting both pain and substance use disorders would greatly increase the available treatment options for veterans with these conditions.
Project Objectives: This project is designed to test the effect of a CBT intervention for patients with chronic pain who are already engaged in VA treatment for substance use disorders compared to an educational supportive condition on measures of pain intensity, pain-related disability and pain-tolerance. A set of secondary analyses will examine if group CBT compared to the educational supportive condition is associated with greater reductions in illicit substance use over the follow-up time period and whether during-treatment reductions in pain mediate the effect of treatment assignment on later substance use. Finally, a series of secondary analyses will explore whether the hypothesized mechanisms of action for the CBT intervention mediate the effect of this intervention on pain intensity and pain tolerance.
Methods: The proposed study is a randomized controlled trial of group-based CBT compared to an educational supportive condition in patients currently receiving drug and alcohol treatment. At least 128 Veterans with alcohol or drug abuse or dependence and at least moderate pain currently treated in the Ann Arbor VA Substance Use Disorder treatment clinic will be assessed at baseline and then randomly assigned to one of these two conditions. These patients will be re-assessed at 3-months (i.e. immediately post treatment), 6-months and 12-months. The primary outcomes will be pain intensity, pain-related disability and pain tolerance. Mixed model regression analyses will be used for all primary analyses to estimate between-group differences in changes in individual slopes over time. Finally, a series of secondary analyses will explore (a) whether the intervention influences post-treatment substance use, (b) if change in pain during treatment mediates the effect of the intervention on subsequent substance use and (c) whether the hypothesized mechanisms of action for the CBT intervention mediate the effect of this intervention on pain intensity and pain tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: cognitive-behavioral treatmentcognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse |
| Arm 2 | Placebo comparator | Behavioral: educational supportive groupeducational supportive group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-behavioral treatmentcognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse | Behavioural | Arm 1 |
| educational supportive groupA control condition providing social support and education about pain and/or drug use. | Behavioural | Arm 2 |
Primary outcome
Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)
Time frame: Baseline, 3-, 6-, & 12-months
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.
The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)
Time frame: Baseline, 3-,6-, 12-month
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.
Alcohol Use
Time frame: Baseline, 3-, 6-, 12- months
#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.
Drug Use
Time frame: Baseline, 3-, 6-, 12- months
# 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.
Pain Tolerance
Time frame: Baseline, 3-,6-,12-months
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.
4 secondary outcomes
Self-efficacy of Pain Management
Time frame: Baseline, 3-, 6-, 12- months
Self-efficacy of Physical Functioning
Time frame: Baseline, 3-, 6-, 12- months
As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)
Time frame: Baseline, 3-, 6-, 12-months
As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)
Time frame: Baseline, 3mo, 6mo, 12mo follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Ilgen, PhD principal investigator
VA Ann Arbor Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cognitive-behavioral treatment and educational supportive group in people with Chronic Pain, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1) (time frame: Baseline, 3-, 6-, & 12-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.