Chronic PainCPODATNCT00727675
Chronic Pain and Opioid Dependence Assessment and Treatment
A study testing Integrated Cognitive Behavioral Therapy in people with Chronic Pain and Opioid Dependency, run by Yale University at 1 site in United States.
Trial summary
This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Opioid Dependency
- What is being tested?
- Integrated Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- currently in Methadone Maintenance Treatment (MMT) at the APT Foundation in New Haven, CT
- opioid dependence
- experience moderate to severe chronic pain
Who cannot join
- current suicide or homicide risk
- are unable to complete the informed consent or surveys because of psychiatric impairment
- have cognitive impairment
- are unable to read or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).
Read the detailed description
To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain intensity and pain interference on self-report measures from baseline throughout treatment) for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative feedback from individual exit interviews, and c) develop and modify initial therapist training and process rating measures. Products will include a) a manual for integrated CBT for POD to be used in opioid treatment programs and primary care settings with POD patients, b) therapist training materials, and c) process rating instruments.
- Conditions
- Chronic Pain, Opioid Dependency
- Being tested
- Integrated Cognitive Behavioral Therapy
- Keywords
- chronic pain, opioid dependence, Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Cognitive Behavioral TherapyBehavioural
CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Integrated Cognitive Behavioral Therapy for pain reduction and opioid dependence. Receives: Behavioral: Integrated Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced illicit opioid use and pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Declan T. Barry, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727675
- Sponsor's protocol ID
- 0703002496
- Other IDs
- 1K23DA024050-01A1
- Acronym
- CPODAT
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2008
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.
PubMed 27574837
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain and Opioid Dependence Assessment and Treatment
- ClinicalTrials.gov ID
- NCT00727675
- Acronym / sponsor ID
- CPODAT / 0703002496
- Conditions
- Chronic Pain, Opioid Dependency
- Keywords
- chronic pain, opioid dependence, Cognitive Behavioral Therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves the development of an integrated psychotherapy that addresses both chronic pain and opioid dependence(POD).
Detailed description
To conduct a pre-pilot study with 20 POD patients to a) evaluate the acceptability and potential efficacy of specific sessions (i.e., reduced illicit opioid use as assessed by urine toxicology and self-report findings, and decreased pain as evidenced by attenuated pain intensity and pain interference on self-report measures from baseline throughout treatment) for inclusion in integrated Cognitive Behavioral Therapy (CBT) for POD and the sequence of sessions, b) assess patients' satisfaction with integrated CBT as evidenced by qualitative feedback from individual exit interviews, and c) develop and modify initial therapist training and process rating measures. Products will include a) a manual for integrated CBT for POD to be used in opioid treatment programs and primary care settings with POD patients, b) therapist training materials, and c) process rating instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Integrated Cognitive Behavioral TherapyIntegrated Cognitive Behavioral Therapy for pain reduction and opioid dependence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years of age
- currently in Methadone Maintenance Treatment (MMT) at the APT Foundation in New Haven, CT
- opioid dependence
- experience moderate to severe chronic pain
Key exclusion criteria (4 listed)
- current suicide or homicide risk
- are unable to complete the informed consent or surveys because of psychiatric impairment
- have cognitive impairment
- are unable to read or understand English
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 |
|---|---|---|
| Integrated Cognitive Behavioral TherapyCBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management. | Behavioural | 1 |
Primary outcome
Reduced illicit opioid use and pain
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 27574837Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.
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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.
Declan T. Barry, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Cognitive Behavioral Therapy in people with Chronic Pain and Opioid Dependency, run by Yale University 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 4 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 3 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduced illicit opioid use and pain (time frame: 12 weeks). 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 NCT00727675, which also lists 1 linked publication.
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 3 Apr 2020.