Opioid-use DisorderPhase 1/2NCT03580902
CBT4CBT for Office Based Buprenorphine
A Phase 1/2 study testing CBT4CBT-Buprenorphine and Buprenorphine/naloxone in people with Opioid-use Disorder, run by CBT4CBT, LLC at 1 site in United States.
Trial summary
In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- CBT4CBT-Buprenorphine and Buprenorphine/naloxone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 1 Aug 2022
- 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
- Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder
- Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation
Who cannot join
- Unstabilized psychotic disorder
- Currently suicidal or homicidal
- Current cocaine, benzodiazepine, or alcohol use disorder.
- Any history of PCP (phencyclidine) use.
- Pregnant or lactating
- Any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Medical Unit of the APT Foundation
New Haven, Connecticut, 06511-5991
About this study
Official title: A Method to Increase Buprenorphine Treatment Capacity
In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).
Read the detailed description
In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.
- Conditions
- Opioid-use Disorder
- Being tested
- CBT4CBT-Buprenorphine, Buprenorphine/naloxone
- 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.
CBT4CBT-BuprenorphineBehavioural
Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment
Buprenorphine/naloxoneDrug
Standard outpatient buprenorphine maintenance
| Study group | Role | What they receive |
|---|---|---|
| Standard Buprenorphine | Active comparator | Participants assigned to this arm will received buprenorphine treatment consistent with standard practice at the study site. This includes induction by a physician, regular meetings with a physician for medical management, urine monitoring, and prescription of buprenorphine, with access to behavioral support services. Receives: Drug: Buprenorphine/naloxone |
| Standard Buprenorphine plus CBT4CBT-Buprenorphine | Experimental | Participants in this condition will receive Standard Buprenorphine as described above, with the addition of access to the CBT4CBT-Buprenorphine program, which is a web-based program that covers basic knowledge about buprenorphine treatment as well as teaches cognitive and behavioral coping skills. Receives: Behavioral: CBT4CBT-Buprenorphine; Drug: Buprenorphine/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of urine toxicology screens that are negative for opioids by group.
Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start22 Jan 2019
- Primary completion23 Nov 2021
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- CBT4CBT, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Shi, MD, Principal investigator, APT Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580902
- Sponsor's protocol ID
- 41941
- Status last verified
- Jan 2023
- First submitted
- 25 Jun 2018
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Method to Increase Buprenorphine Treatment Capacity
- ClinicalTrials.gov ID
- NCT03580902
- Acronym / sponsor ID
- 41941
- Conditions
- Opioid-use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CBT4CBT, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 10 Jul 2018 (actual)
- 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.
In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).
Detailed description
In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Buprenorphine | Active comparator | Drug: Buprenorphine/naloxoneParticipants assigned to this arm will received buprenorphine treatment consistent with standard practice at the study site. This includes induction by a physician, regular meetings with a physician for medical management, urine monitoring, and prescription of buprenorphine, with access to behavioral support services. |
| Standard Buprenorphine plus CBT4CBT-Buprenorphine | Experimental | Behavioral: CBT4CBT-Buprenorphine, Drug: Buprenorphine/naloxoneParticipants in this condition will receive Standard Buprenorphine as described above, with the addition of access to the CBT4CBT-Buprenorphine program, which is a web-based program that covers basic knowledge about buprenorphine treatment as well as teaches cognitive and behavioral coping skills. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder
- Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation
Key exclusion criteria (6 listed)
- Unstabilized psychotic disorder
- Currently suicidal or homicidal
- Current cocaine, benzodiazepine, or alcohol use disorder.
- Any history of PCP (phencyclidine) use.
- Pregnant or lactating
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 |
|---|---|---|
| CBT4CBT-BuprenorphineComputerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment | Behavioural | Standard Buprenorphine plus CBT4CBT-Buprenorphine |
| Buprenorphine/naloxoneStandard outpatient buprenorphine maintenance | Drug | Standard Buprenorphine, Standard Buprenorphine plus CBT4CBT-Buprenorphine |
Primary outcome
Percent of urine toxicology screens that are negative for opioids by group.
Time frame: 12 weeks
Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.
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 4 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Julia Shi, MD principal investigator
APT Foundation, Inc.
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 CBT4CBT-Buprenorphine and Buprenorphine/naloxone in people with Opioid-use Disorder, run by CBT4CBT, LLC 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 2 inclusion and 6 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 4 Jan 2023. 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?
Percent of urine toxicology screens that are negative for opioids by group. (time frame: 12 weeks). 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 4 Jan 2023.