Chronic PainNCT02423772

Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse

A study testing Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU) in people with Chronic Pain and Problematic Opioid Use, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Chronic Pain, Problematic Opioid Use
What is being tested?: Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Jul 2018
Phase: Interventional
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 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Raymond G. Murphy VA Medical Center
Albuquerque, New Mexico, 87108

Other trials in United States

About this study

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.

Read the 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.

Conditions: Chronic Pain, Problematic Opioid Use
Being tested: Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)Behavioural

Study groups in NCT02423772
Study group	Role	What they receive
Intervention	Experimental	Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use. Receives: Behavioral: Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)
Treatment as Usual	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
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.
Measured: 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).
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.
Measured: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jul 2018

First posted22 Apr 2015 (estimated)
Study startAug 2014
Primary completionJul 2018
Study completionJul 2018

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.
Publications (9)Papers the sponsor has linked to this study.
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: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02423772
Sponsor's protocol ID: AT008398-01
Status last verified: Aug 2024
First submitted: 9 Apr 2015
Last updated: 8 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Pielech M, Kruger E, Rivers WE, Snow HE, Vowles KE. Receipt of multiple outpatient opioid prescriptions is associated with increased risk of adverse outcomes in youth: opioid prescribing trends, individual characteristics, and outcomes from 2005 to 2016. Pain. 2020 Jun;161(6):1297-1310. doi: 10.1097/j.pain.0000000000001812.
PubMed 31977934
Witkiewitz K, Votaw VR, Vowles KE, Kranzler HR. Opioid Misuse as a Predictor of Alcohol Treatment Outcomes in the COMBINE Study: Mediation by Medication Adherence. Alcohol Clin Exp Res. 2018 Jul;42(7):1249-1259. doi: 10.1111/acer.13772. Epub 2018 Jun 9.
PubMed 29873089
Vowles KE, Bailey RW, McEntee ML, Pielech M, Edwards KA, Bolling LA, Rivers WE. Using Analgesics for Emotional Modulation is Associated With Increased Distress, Depression, and Risk of Opioid and Alcohol Misuse: Initial Evaluation and Component Analysis of the Reasons for Analgesic Use Measure (RAUM). Clin J Pain. 2018 Oct;34(10):975-982. doi: 10.1097/AJP.0000000000000621.
PubMed 29697475
Witkiewitz K, Vowles KE. Alcohol and Opioid Use, Co-Use, and Chronic Pain in the Context of the Opioid Epidemic: A Critical Review. Alcohol Clin Exp Res. 2018 Mar;42(3):478-488. doi: 10.1111/acer.13594. Epub 2018 Feb 6.
PubMed 29314075
Bailey RW, Vowles KE. Using Screening Tests to Predict Aberrant Use of Opioids in Chronic Pain Patients: Caveat Emptor. J Pain. 2017 Dec;18(12):1427-1436. doi: 10.1016/j.jpain.2017.06.004. Epub 2017 Jun 29.
PubMed 28669863
Pielech M, Vowles KE, Wicksell R. Acceptance and Commitment Therapy for Pediatric Chronic Pain: Theory and Application. Children (Basel). 2017 Jan 30;4(2):10. doi: 10.3390/children4020010.
PubMed 28146108
Witkiewitz K, McCallion E, Vowles KE, Kirouac M, Frohe T, Maisto SA, Hodgson R, Heather N. Association between physical pain and alcohol treatment outcomes: The mediating role of negative affect. J Consult Clin Psychol. 2015 Dec;83(6):1044-57. doi: 10.1037/ccp0000033. Epub 2015 Jun 22.
PubMed 26098375
Witkiewitz K, Vowles KE, McCallion E, Frohe T, Kirouac M, Maisto SA. Pain as a predictor of heavy drinking and any drinking lapses in the COMBINE study and the UK Alcohol Treatment Trial. Addiction. 2015 Aug;110(8):1262-71. doi: 10.1111/add.12964. Epub 2015 Jun 3.
PubMed 25919978
Vowles KE, Witkiewitz K, Cusack KJ, Gilliam WP, Cardon KE, Bowen S, Edwards KA, McEntee ML, Bailey RW. Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. J Pain. 2020 Jul-Aug;21(7-8):798-807. doi: 10.1016/j.jpain.2019.11.007. Epub 2019 Nov 21.
PubMed 31760109

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse
ClinicalTrials.gov ID: NCT02423772
Acronym / sponsor ID: AT008398-01
Conditions: Chronic Pain, Problematic Opioid Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Study start: Aug 2014 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 22 Apr 2015 (estimated)
Results: Posted 8 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Treatment as Usual	No intervention	–

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

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
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)	Behavioural	Intervention

Primary outcome

Patient Reported Outcomes Measurement Information System (PROMIS) - 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).
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
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).
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)
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
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.

Results and safety

Results posted to the registry on 8 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	17	12
Treatment as Usual	18	10

Primary outcome: Patient Reported Outcomes Measurement Information System (PROMIS) - 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).. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 17	Treatment as Usual n = 18
Baseline	66.7 (6.6)	66.0 (6.6)
6 month follow-up	64.3 (9.2)	66.8 (8.0)

Population analysed: Per protocol analysis

Primary outcome: Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference

Measure	Intervention n = 17	Treatment as Usual n = 18
Baseline	66.7 (6.6)	65.2 (6.8)
6 month follow-up	64.3 (9.2)	70.1 (4.9)

Population analysed: Per protocol analysis

Primary outcome: Current Opioid Misuse Measure (COMM)

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. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 17	Treatment as Usual n = 18
Baseline	16.2 (8.8)	17.4 (7.8)
6 month follow-up	10.6 (6.5)	16.1 (8.5)

Population analysed: Per protocol analysis

Adverse events

Time frame: Study period was (9 months) to include the three month intervention period and six month post-intervention follow-up period. Specific dates of the study period was from 21 April 2015 through 13 March 2018.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Treatment as Usual	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): This was a pilot trial intended to test feasibility and a preliminary test of efficacy. Sample size was small, which places limits on generalizability and power. TAU did not include a active psychotherapy comparator. The study was under-recruited, which indicates poorer than expected feasibility. Finally, we did not assess therapist competency in treatment delivery; we did assess adherence to the protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31977934Pielech M, Kruger E, Rivers WE, Snow HE, Vowles KE. Receipt of multiple outpatient opioid prescriptions is associated with increased risk of adverse outcomes in youth: opioid prescribing trends, individual characteristics, and outcomes from 2005 to 2016. Pain. 2020 Jun;161(6):1297-1310. doi: 10.1097/j.pain.0000000000001812.
Background: PubMed 29873089Witkiewitz K, Votaw VR, Vowles KE, Kranzler HR. Opioid Misuse as a Predictor of Alcohol Treatment Outcomes in the COMBINE Study: Mediation by Medication Adherence. Alcohol Clin Exp Res. 2018 Jul;42(7):1249-1259. doi: 10.1111/acer.13772. Epub 2018 Jun 9.
Background: PubMed 29697475Vowles KE, Bailey RW, McEntee ML, Pielech M, Edwards KA, Bolling LA, Rivers WE. Using Analgesics for Emotional Modulation is Associated With Increased Distress, Depression, and Risk of Opioid and Alcohol Misuse: Initial Evaluation and Component Analysis of the Reasons for Analgesic Use Measure (RAUM). Clin J Pain. 2018 Oct;34(10):975-982. doi: 10.1097/AJP.0000000000000621.
Background: PubMed 29314075Witkiewitz K, Vowles KE. Alcohol and Opioid Use, Co-Use, and Chronic Pain in the Context of the Opioid Epidemic: A Critical Review. Alcohol Clin Exp Res. 2018 Mar;42(3):478-488. doi: 10.1111/acer.13594. Epub 2018 Feb 6.
Background: PubMed 28669863Bailey RW, Vowles KE. Using Screening Tests to Predict Aberrant Use of Opioids in Chronic Pain Patients: Caveat Emptor. J Pain. 2017 Dec;18(12):1427-1436. doi: 10.1016/j.jpain.2017.06.004. Epub 2017 Jun 29.
Background: PubMed 28146108Pielech M, Vowles KE, Wicksell R. Acceptance and Commitment Therapy for Pediatric Chronic Pain: Theory and Application. Children (Basel). 2017 Jan 30;4(2):10. doi: 10.3390/children4020010.
Background: PubMed 26098375Witkiewitz K, McCallion E, Vowles KE, Kirouac M, Frohe T, Maisto SA, Hodgson R, Heather N. Association between physical pain and alcohol treatment outcomes: The mediating role of negative affect. J Consult Clin Psychol. 2015 Dec;83(6):1044-57. doi: 10.1037/ccp0000033. Epub 2015 Jun 22.
Background: PubMed 25919978Witkiewitz K, Vowles KE, McCallion E, Frohe T, Kirouac M, Maisto SA. Pain as a predictor of heavy drinking and any drinking lapses in the COMBINE study and the UK Alcohol Treatment Trial. Addiction. 2015 Aug;110(8):1262-71. doi: 10.1111/add.12964. Epub 2015 Jun 3.
Results publication: PubMed 31760109Vowles KE, Witkiewitz K, Cusack KJ, Gilliam WP, Cardon KE, Bowen S, Edwards KA, McEntee ML, Bailey RW. Integrated Behavioral Treatment for Veterans With Co-Morbid Chronic Pain and Hazardous Opioid Use: A Randomized Controlled Pilot Trial. J Pain. 2020 Jul-Aug;21(7-8):798-807. doi: 10.1016/j.jpain.2019.11.007. Epub 2019 Nov 21.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 4 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 8 Nov 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2024). 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?

Patient Reported Outcomes Measurement Information System (PROMIS) - 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02423772, which also lists 9 linked publications.

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 8 Nov 2024.