Chronic PainPhase 1NCT01334580
Cognitive-Behavioral Therapy for Pain and Opioid Dependence in Methadone Maintenance Treatment
A Phase 1 study testing Cognitive-Behavioral Therapy for Pain and Opioid Dependence and Methadone Drug Counseling in people with Chronic Pain and Opiate Dependence, run by Yale University at 1 site in United States.
Trial summary
This study involves the comparison of two treatment approaches for patients with chronic pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a counseling intervention that addresses opioid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opiate Dependence
- What is being tested?
- Cognitive-Behavioral Therapy for Pain and Opioid Dependence and Methadone Drug Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2014
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- prescription opioid or heroin addiction
- moderate to severe chronic pain
- enrolled in methadone maintenance at the APT Foundation for opioid addiction
- understand English
Who cannot join
- current suicide or homicide risk
- life-threatening or unstable medical problem
Trial locations and contacts
1 site in 1 country.
United States1 site
Methadone Research Unit
New Haven, Connecticut, 06519
About this study
Official title: Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence
This study involves the comparison of two treatment approaches for patients with chronic pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a counseling intervention that addresses opioid dependence only.
- Conditions
- Chronic Pain, Opiate Dependence
- Being tested
- Cognitive-Behavioral Therapy for Pain and Opioid Dependence, Methadone Drug Counseling
- 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.
Cognitive-Behavioral Therapy for Pain and Opioid DependenceBehavioural
CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
Methadone Drug CounselingBehavioural
Methadone Drug Counseling (MDC)is provided by skilled drug counselors over a 12-week period. The primary goal of MDC is cessation of illicit drugs.
| Study group | Role | What they receive |
|---|---|---|
| Methadone Drug Counseling | Active comparator | Methadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs Receives: Behavioral: Methadone Drug Counseling |
| Cognitive-Behavioral Therapy for Pain and Opioid Dependence | Experimental | CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management. Receives: Behavioral: Cognitive-Behavioral Therapy for Pain and Opioid Dependence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Measured: 16 weeks
Reduce illicit opioid use
Measured: 16 weeks
Secondary outcomes (2)
Finalization of treatment manuals
Measured: 16 weeks
Development and modification of therapy training and process rating measures
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 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 Barry, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334580
- Sponsor's protocol ID
- 0703002496_B
- Other IDs
- K23DA024050-03
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2011
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
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
- Comparison of Cognitive-Behavioral Therapy and Methadone Drug Counseling for Methadone-Maintained Patients With Co-occurring Chronic Pain and Opioid Dependence
- ClinicalTrials.gov ID
- NCT01334580
- Acronym / sponsor ID
- 0703002496_B
- Conditions
- Chronic Pain, Opiate Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Apr 2011 (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 comparison of two treatment approaches for patients with chronic pain who are entering methadone maintenance treatment (MMT) for opioid addiction: (a) an integrated counseling that addresses both chronic pain and opioid dependence(POD)and (b) a counseling intervention that addresses opioid dependence only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone Drug Counseling | Active comparator | Behavioral: Methadone Drug CounselingMethadone Drug Counseling is provided by skilled drug counselors over a 12 week period and focuses on cessation of illicit drugs |
| Cognitive-Behavioral Therapy for Pain and Opioid Dependence | Experimental | Behavioral: Cognitive-Behavioral Therapy for Pain and Opioid DependenceCBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- prescription opioid or heroin addiction
- moderate to severe chronic pain
- enrolled in methadone maintenance at the APT Foundation for opioid addiction
- understand English
Key exclusion criteria (2 listed)
- current suicide or homicide risk
- life-threatening or unstable medical problem
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 Therapy for Pain and Opioid DependenceCBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management. | Behavioural | Cognitive-Behavioral Therapy for Pain and Opioid Dependence |
| Methadone Drug CounselingMethadone Drug Counseling (MDC)is provided by skilled drug counselors over a 12-week period. The primary goal of MDC is cessation of illicit drugs. | Behavioural | Methadone Drug Counseling |
Primary outcome
Pain reduction
Time frame: 16 weeks
Reduce illicit opioid use
Time frame: 16 weeks
2 secondary outcomes
Finalization of treatment manuals
Time frame: 16 weeks
Development and modification of therapy training and process rating measures
Time frame: 16 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.
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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 Barry, PhD 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 Phase 1 study testing Cognitive-Behavioral Therapy for Pain and Opioid Dependence and Methadone Drug Counseling in people with Chronic Pain and Opiate Dependence, 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 5 inclusion and 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain reduction (time frame: 16 weeks). The study lists 2 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 3 Apr 2020.