Prescription Opioid DependencePhase 2NCT00719095
Effective Treatment for Prescription Opioid Abuse
A Phase 2 study testing buprenorphine taper followed by naltrexone maintenance and Behavioral therapy in people with Prescription Opioid Dependence, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prescription Opioid Dependence
- What is being tested?
- buprenorphine taper followed by naltrexone maintenance and Behavioral therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Mar 2010
- Phase
- Phase 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
- For inclusion in the proposed studies, subjects must be > 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.
Who cannot join
- Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
- Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Abuse Treatment Center, University of Vermont
Burlington, Vermont, 05401
About this study
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.
Read the detailed description
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.
- Conditions
- Prescription Opioid Dependence
- Being tested
- buprenorphine taper followed by naltrexone maintenance, Behavioral therapy
- Keywords
- prescription opioid, opioid detoxification, buprenorphine, naltrexone, community reinforcement approach, prescription opioid abuse
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buprenorphine taper followed by naltrexone maintenanceDrug
direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial
Behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1-week buprenorphine taper | Experimental | 1-week buprenorphine taper + behavioral therapy + urine toxicology Receives: Drug: buprenorphine taper followed by naltrexone maintenance; Behavioral: Behavioral therapy |
| 2-week buprenorphine taper | Experimental | 2-week buprenorphine taper + behavioral therapy + urine toxicology Receives: Drug: buprenorphine taper followed by naltrexone maintenance; Behavioral: Behavioral therapy |
| 4-week buprenorphine taper | Experimental | 4-week buprenorphine taper + behavioral therapy + urine toxicology Receives: Drug: buprenorphine taper followed by naltrexone maintenance; Behavioral: Behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of subjects abstinent from all opioids through the final day of detoxification
Measured: up to 12-week trial
Secondary outcomes (1)
percentage of subjects retained in treatment through the final day of detoxification
Measured: up to 12-week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionMar 2010
- Study completionMar 2010
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 Prescription Opioid DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Stacey C. Sigmon, Ph.D., Principal investigator, University of Vermont, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719095
- Sponsor's protocol ID
- R01DA019989
- Other IDs
- R01DA019989
- Status last verified
- Jul 2008
- First submitted
- 17 Jul 2008
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sigmon SC, Dunn KE, Saulsgiver K, Patrick ME, Badger GJ, Heil SH, Brooklyn JR, Higgins ST. A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers. JAMA Psychiatry. 2013 Dec;70(12):1347-54. doi: 10.1001/jamapsychiatry.2013.2216.
PubMed 24153411
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Treatment for Prescription Opioid Abuse
- ClinicalTrials.gov ID
- NCT00719095
- Acronym / sponsor ID
- R01DA019989
- Conditions
- Prescription Opioid Dependence
- Keywords
- prescription opioid, opioid detoxification, buprenorphine, naltrexone, community reinforcement approach, prescription opioid abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Jul 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.
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.
Detailed description
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-week buprenorphine taper | Experimental | Drug: buprenorphine taper followed by naltrexone maintenance, Behavioral: Behavioral therapy1-week buprenorphine taper + behavioral therapy + urine toxicology |
| 2-week buprenorphine taper | Experimental | Drug: buprenorphine taper followed by naltrexone maintenance, Behavioral: Behavioral therapy2-week buprenorphine taper + behavioral therapy + urine toxicology |
| 4-week buprenorphine taper | Experimental | Drug: buprenorphine taper followed by naltrexone maintenance, Behavioral: Behavioral therapy4-week buprenorphine taper + behavioral therapy + urine toxicology |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For inclusion in the proposed studies, subjects must be > 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.
Key exclusion criteria (2 listed)
- Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
- Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.
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 |
|---|---|---|
| buprenorphine taper followed by naltrexone maintenancedirect comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial | Drug | 1-week buprenorphine taper, 2-week buprenorphine taper, 4-week buprenorphine taper |
| Behavioral therapy | Behavioural | 1-week buprenorphine taper, 2-week buprenorphine taper, 4-week buprenorphine taper |
Primary outcome
percentage of subjects abstinent from all opioids through the final day of detoxification
Time frame: up to 12-week trial
1 secondary outcome
percentage of subjects retained in treatment through the final day of detoxification
Time frame: up to 12-week trial
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 15 Apr 2013.
- Derived from this study: PubMed 24153411Sigmon SC, Dunn KE, Saulsgiver K, Patrick ME, Badger GJ, Heil SH, Brooklyn JR, Higgins ST. A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers. JAMA Psychiatry. 2013 Dec;70(12):1347-54. doi: 10.1001/jamapsychiatry.2013.2216.
Related trials for Prescription Opioid Dependence
Enrolling by invitationPhase 4
Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill Quantity
Opioid Abuse (Disorder), Opioid Analgesia
RecruitingPhase 4
Young Houston Emergency Opioid Engagement System
Opioid-use Disorder, Opioid Dependence
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.
Stacey C. Sigmon, Ph.D. principal investigator
University of Vermont, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing buprenorphine taper followed by naltrexone maintenance and Behavioral therapy in people with Prescription Opioid Dependence, run by University of Vermont Medical Center 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 1 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 15 Apr 2013. 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 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?
percentage of subjects abstinent from all opioids through the final day of detoxification (time frame: up to 12-week trial). 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 NCT00719095, 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 15 Apr 2013.