Chronic PainPhase 1/2YogaNCT01590251
Yoga for Pain and Opioid Dependence
A Phase 1/2 study testing Yoga and Educational Counseling in people with Chronic Pain and Opioid Addiction, run by Yale University at 1 site in United States.
Trial summary
This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Opioid Addiction
- What is being tested?
- Yoga and Educational Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Nov 2014
- Phase
- Phase 1/2
- 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
- 18 years of age or older
- Prescription opioid addiction or heroin addiction
- Moderate to severe chronic pain,
- Understands English
Who cannot join
- Current suicide or homicide risk
- Life threatening or unstable medical condition
- Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.
Read the detailed description
This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD).
Specific Aims:
- To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.
- Conditions
- Chronic Pain, Opioid Addiction
- Being tested
- Yoga, Educational Counseling
- Keywords
- Pain, Addiction, Buprenorphine, Counseling, Methadone, Yoga
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders, Pain, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.
Educational CounselingBehavioural
One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Gentle yoga for chronic pain and opioid dependence Receives: Other: Yoga |
| Educational Counseling | Active comparator | Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment. Receives: Behavioral: Educational Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Pain reduction will be measured by patient self-report using standard pain rating scales.
Measured: 8 weeks
Reduce illicit opioid use
Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2014
- Study completionNov 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Declan T Barry, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590251
- Sponsor's protocol ID
- 1111009292
- Acronym
- Yoga
- Status last verified
- Sep 2015
- First submitted
- 30 Apr 2012
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Pain and Opioid Dependence
- ClinicalTrials.gov ID
- NCT01590251
- Acronym / sponsor ID
- Yoga / 1111009292
- Conditions
- Chronic Pain, Opioid Addiction
- Keywords
- Pain, Addiction, Buprenorphine, Counseling, Methadone, Yoga
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 May 2012 (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 is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.
Detailed description
This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD).
Specific Aims:
- To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: YogaGentle yoga for chronic pain and opioid dependence |
| Educational Counseling | Active comparator | Behavioral: Educational CounselingEducational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Prescription opioid addiction or heroin addiction
- Moderate to severe chronic pain,
- Understands English
Key exclusion criteria (4 listed)
- Current suicide or homicide risk
- Life threatening or unstable medical condition
- Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician
- Pregnancy
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 |
|---|---|---|
| YogaTwo yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session. | Other | Yoga |
| Educational CounselingOne didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders. | Behavioural | Educational Counseling |
Primary outcome
Pain reduction
Time frame: 8 weeks
Pain reduction will be measured by patient self-report using standard pain rating scales.
Reduce illicit opioid use
Time frame: 8 weeks
Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.
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 25 Sep 2015.
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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 Phase 1/2 study testing Yoga and Educational Counseling in people with Chronic Pain and Opioid Addiction, 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 25 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 8 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 25 Sep 2015.