Opiate DependencePhase 4NCT00595764
Counseling for Primary Care Office-based Buprenorphine
A Phase 4 study testing Manual-guided Physician Management (PM) and Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in people with Opiate Dependence, run by Yale University at 2 sites in United States.
Trial summary
The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Manual-guided Physician Management (PM) and Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Feb 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- opioid dependence
Who cannot join
- current dependence on alcohol, cocaine, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or untreated major depression
- inability to read or understand English
- life-threatening or unstable medical problems
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The APT Foundation, Inc. -- Welch Building
New Haven, Connecticut, 06519
Yale New Haven Hospital Primary Care Center
New Haven, Connecticut, 06519
About this study
The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting.
Read the detailed description
To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved buprenorphine/naloxone adherence and will demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine/naloxone.
- Conditions
- Opiate Dependence
- Being tested
- Manual-guided Physician Management (PM), Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
- Keywords
- Buprenorphine, Buprenorphine/naloxone, Counseling, Primary care
- 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.
Manual-guided Physician Management (PM)Behavioural
Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.
Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)Behavioural
CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Physician Management Receives: Behavioral: Manual-guided Physician Management (PM) |
| 2 | Experimental | Physician Management plus Cognitive Behavioral Therapy Receives: Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit Opioid Abstinence
number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.
Measured: 6 months
Secondary outcomes (4)
Treatment Completion
The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.
Measured: 6 months
Cocaine Abstinence
Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.
Measured: 6 months
Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.
The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.
Measured: 6 months
Overall Health- Short Form (36) Health Survey
Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales.
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startAug 2005
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 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
- David A. Fiellin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595764
- Sponsor's protocol ID
- 0504027657
- Other IDs
- 5R01DA019511
- Status last verified
- Apr 2020
- First submitted
- 3 Oct 2007
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005.
PubMed 23260506McHugh RK, Bailey AJ, McConaghy BA, Weiss RD, Fiellin DA, Hillhouse M, Moore BA, Fitzmaurice GM. Behavioral Therapy as an Adjunct to Buprenorphine Treatment for Opioid Use Disorder: A Secondary Analysis of 4 Randomized Clinical Trials. JAMA Netw Open. 2025 Aug 1;8(8):e2528529. doi: 10.1001/jamanetworkopen.2025.28529.
PubMed 40833692
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
- Counseling for Primary Care Office-based Buprenorphine
- ClinicalTrials.gov ID
- NCT00595764
- Acronym / sponsor ID
- 0504027657
- Conditions
- Opiate Dependence
- Keywords
- Buprenorphine, Buprenorphine/naloxone, Counseling, Primary care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting.
Detailed description
To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved buprenorphine/naloxone adherence and will demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine/naloxone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Manual-guided Physician Management (PM)Physician Management |
| 2 | Experimental | Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)Physician Management plus Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- opioid dependence
Key exclusion criteria (5 listed)
- current dependence on alcohol, cocaine, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or untreated major depression
- inability to read or understand English
- life-threatening or unstable medical problems
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 |
|---|---|---|
| Manual-guided Physician Management (PM)Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. | Behavioural | 1 |
| Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence. | Behavioural | 2 |
Primary outcome
Illicit Opioid Abstinence
Time frame: 6 months
number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.
4 secondary outcomes
Treatment Completion
Time frame: 6 months
Cocaine Abstinence
Time frame: 6 months
Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.
Time frame: 6 months
Overall Health- Short Form (36) Health Survey
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23260506Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005.
- Derived from this study: PubMed 40833692McHugh RK, Bailey AJ, McConaghy BA, Weiss RD, Fiellin DA, Hillhouse M, Moore BA, Fitzmaurice GM. Behavioral Therapy as an Adjunct to Buprenorphine Treatment for Opioid Use Disorder: A Secondary Analysis of 4 Randomized Clinical Trials. JAMA Netw Open. 2025 Aug 1;8(8):e2528529. doi: 10.1001/jamanetworkopen.2025.28529.
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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.
David A. Fiellin, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manual-guided Physician Management (PM) and Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in people with Opiate Dependence, run by Yale University at 2 sites 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 5 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 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Illicit Opioid Abstinence (time frame: 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 NCT00595764, which also lists 2 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 3 Apr 2020.