Substance AbuseNCT00988962
Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy
A study testing cognitive behavioral training in people with Substance Abuse, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- cognitive behavioral training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic pain for >6 months
- history of taking daily opioids for pain for >6 months
- average >3 on a pain intensity scale of 0 to 10 over past week
- able to speak and understand English
- chronic neck or back pain as primary pain complaint
- willingness to participate
Who cannot join
- current opioid addiction (M.I.N.I. Section K)
- current diagnosis of cancer or any other malignant disease
- acute osteomyelitis or acute bone disease
- nonambulatory
- present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder
- pregnancy
Show all 9Show fewer
- any clinically unstable systemic illness judged to interfere with treatment
- an acute condition requiring surgery
- taking opioids intermittently
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital Pain Management Center
Chestnut Hill, Massachusetts, 02467
About this study
Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.
Read the detailed description
This study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.
- Conditions
- Substance Abuse
- Being tested
- cognitive behavioral training
- Keywords
- pain, opioids
- Medical subject headings
- Substance-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral trainingBehavioural
Also called compliance contract, therapy
electronic diaries, compliance checklists, urine screens, individual and group motivational counseling
| Study group | Role | What they receive |
|---|---|---|
| High-Risk No Treatment | No intervention | Not described |
| High-Risk Treatment | Experimental | Not described Receives: Behavioral: cognitive behavioral training |
| Low-Risk | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens
Measured: All subjects will be followed for 6 months.
Secondary outcomes (1)
1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings
Measured: Subjects will be followed for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Robert N Jamison, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988962
- Sponsor's protocol ID
- 2007p001732
- Status last verified
- Jun 2011
- First submitted
- 30 Sep 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wasan AD, Butler SF, Budman SH, Fernandez K, Weiss RD, Greenfield SF, Jamison RN. Does report of craving opioid medication predict aberrant drug behavior among chronic pain patients? Clin J Pain. 2009 Mar-Apr;25(3):193-8. doi: 10.1097/AJP.0b013e318193a6c4.
PubMed 19333168Wasan AD, Michna E, Janfaza D, Greenfield S, Teter CJ, Jamison RN. Interpreting urine drug tests: prevalence of morphine metabolism to hydromorphone in chronic pain patients treated with morphine. Pain Med. 2008 Oct;9(7):918-23. doi: 10.1111/j.1526-4637.2007.00354.x. Epub 2007 Aug 28.
PubMed 18616432Butler SF, Fernandez K, Benoit C, Budman SH, Jamison RN. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008 Apr;9(4):360-72. doi: 10.1016/j.jpain.2007.11.014. Epub 2008 Jan 22.
PubMed 18203666Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med. 2007 Oct;8 Suppl 3:S101-9. doi: 10.1111/j.1526-4637.2007.00374.x.
PubMed 17877520Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. doi: 10.1016/j.pain.2007.01.014. Epub 2007 May 9.
PubMed 17493754Akbik H, Butler SF, Budman SH, Fernandez K, Katz NP, Jamison RN. Validation and clinical application of the Screener and Opioid Assessment for Patients with Pain (SOAPP). J Pain Symptom Manage. 2006 Sep;32(3):287-93. doi: 10.1016/j.jpainsymman.2006.03.010.
PubMed 16939853Butler SF, Budman SH, Fernandez K, Jamison RN. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004 Nov;112(1-2):65-75. doi: 10.1016/j.pain.2004.07.026.
PubMed 15494186Michna E, Ross EL, Hynes WL, Nedeljkovic SS, Soumekh S, Janfaza D, Palombi D, Jamison RN. Predicting aberrant drug behavior in patients treated for chronic pain: importance of abuse history. J Pain Symptom Manage. 2004 Sep;28(3):250-8. doi: 10.1016/j.jpainsymman.2004.04.007.
PubMed 15336337Nedeljkovic SS, Wasan A, Jamison RN. Assessment of efficacy of long-term opioid therapy in pain patients with substance abuse potential. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S39-51. doi: 10.1097/00002508-200207001-00005.
PubMed 12479253
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy
- ClinicalTrials.gov ID
- NCT00988962
- Acronym / sponsor ID
- 2007p001732
- Conditions
- Substance Abuse
- Keywords
- pain, opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Oct 2009 (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.
Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.
Detailed description
This study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Risk No Treatment | No intervention | – |
| High-Risk Treatment | Experimental | Behavioral: cognitive behavioral training |
| Low-Risk | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- chronic pain for >6 months
- history of taking daily opioids for pain for >6 months
- average >3 on a pain intensity scale of 0 to 10 over past week
- able to speak and understand English
- chronic neck or back pain as primary pain complaint
Key exclusion criteria (9 listed)
- current opioid addiction (M.I.N.I. Section K)
- current diagnosis of cancer or any other malignant disease
- acute osteomyelitis or acute bone disease
- nonambulatory
- present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder
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 trainingAlso: compliance contract, therapyelectronic diaries, compliance checklists, urine screens, individual and group motivational counseling | Behavioural | High-Risk Treatment |
Primary outcome
Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens
Time frame: All subjects will be followed for 6 months.
1 secondary outcome
1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings
Time frame: Subjects will be followed for 6 months.
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 27 Jun 2011.
- Background: PubMed 19333168Wasan AD, Butler SF, Budman SH, Fernandez K, Weiss RD, Greenfield SF, Jamison RN. Does report of craving opioid medication predict aberrant drug behavior among chronic pain patients? Clin J Pain. 2009 Mar-Apr;25(3):193-8. doi: 10.1097/AJP.0b013e318193a6c4.
- Background: PubMed 18616432Wasan AD, Michna E, Janfaza D, Greenfield S, Teter CJ, Jamison RN. Interpreting urine drug tests: prevalence of morphine metabolism to hydromorphone in chronic pain patients treated with morphine. Pain Med. 2008 Oct;9(7):918-23. doi: 10.1111/j.1526-4637.2007.00354.x. Epub 2007 Aug 28.
- Background: PubMed 18203666Butler SF, Fernandez K, Benoit C, Budman SH, Jamison RN. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008 Apr;9(4):360-72. doi: 10.1016/j.jpain.2007.11.014. Epub 2008 Jan 22.
- Background: PubMed 17877520Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med. 2007 Oct;8 Suppl 3:S101-9. doi: 10.1111/j.1526-4637.2007.00374.x.
- Background: PubMed 17493754Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. doi: 10.1016/j.pain.2007.01.014. Epub 2007 May 9.
- Background: PubMed 16939853Akbik H, Butler SF, Budman SH, Fernandez K, Katz NP, Jamison RN. Validation and clinical application of the Screener and Opioid Assessment for Patients with Pain (SOAPP). J Pain Symptom Manage. 2006 Sep;32(3):287-93. doi: 10.1016/j.jpainsymman.2006.03.010.
- Background: PubMed 15494186Butler SF, Budman SH, Fernandez K, Jamison RN. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004 Nov;112(1-2):65-75. doi: 10.1016/j.pain.2004.07.026.
- Background: PubMed 15336337Michna E, Ross EL, Hynes WL, Nedeljkovic SS, Soumekh S, Janfaza D, Palombi D, Jamison RN. Predicting aberrant drug behavior in patients treated for chronic pain: importance of abuse history. J Pain Symptom Manage. 2004 Sep;28(3):250-8. doi: 10.1016/j.jpainsymman.2004.04.007.
- Background: PubMed 12479253Nedeljkovic SS, Wasan A, Jamison RN. Assessment of efficacy of long-term opioid therapy in pain patients with substance abuse potential. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S39-51. doi: 10.1097/00002508-200207001-00005.
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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.
Robert N Jamison, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral training in people with Substance Abuse, run by Brigham and Women's Hospital 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 6 inclusion and 9 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 27 Jun 2011. 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?
Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens (time frame: All subjects will be followed for 6 months.). 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 NCT00988962, 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 27 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.