Drug DependenceNCT01096550
Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
A study testing Outpatient and Intensive Outpatient in people with Drug Dependence, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Drug Dependence
- What is being tested?
- Outpatient and Intensive Outpatient
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2011
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- heroin-dependent adults
- new admissions to buprenorphine outpatient treatment
Who cannot join
- pregnancy
- acute medical or psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Research Institute
Baltimore, Maryland, 21201
About this study
Official title: Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans
The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.
Read the detailed description
This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.
- Conditions
- Drug Dependence
- Being tested
- Outpatient, Intensive Outpatient
- Keywords
- opioid dependence, outpatient treatment, intensive outpatient treatment
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutpatientBehavioural
Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Intensive OutpatientBehavioural
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Outpatient | Experimental | Buprenorphine patients receiving 9 or more hours of outpatient counseling. Receives: Behavioral: Intensive Outpatient |
| Outpatient | Active comparator | Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling. Receives: Behavioral: Outpatient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 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.
- Other trials for Drug 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Shannon G Mitchell, PhD, Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096550
- Sponsor's protocol ID
- 1RC1DA028407-01
- Other IDs
- 1RC1DA028407-01
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2010
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans
- ClinicalTrials.gov ID
- NCT01096550
- Acronym / sponsor ID
- 1RC1DA028407-01
- Conditions
- Drug Dependence
- Keywords
- opioid dependence, outpatient treatment, intensive outpatient treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 17 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.
Detailed description
This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Outpatient | Experimental | Behavioral: Intensive OutpatientBuprenorphine patients receiving 9 or more hours of outpatient counseling. |
| Outpatient | Active comparator | Behavioral: OutpatientBuprenorphine patients receiving between 2 and 8 hours of outpatient counseling. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- heroin-dependent adults
- new admissions to buprenorphine outpatient treatment
Key exclusion criteria (2 listed)
- pregnancy
- acute medical or psychiatric illness
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 |
|---|---|---|
| OutpatientBuprenorphine patients receiving 2 to 8 hours of outpatient counseling. | Behavioural | Outpatient |
| Intensive OutpatientBuprenorphine patients receiving 9 or more hours of outpatient counseling. | Behavioural | Intensive Outpatient |
Primary outcome
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
Time frame: 6 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shannon G Mitchell, PhD principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient and Intensive Outpatient in people with Drug Dependence, run by Friends Research Institute, Inc. 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 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 8 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 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?
Yes. Results are posted in the registry (first posted 17 Oct 2013). 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?
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) (time frame: 6 months post-baseline). 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 8 Apr 2020.