Drug UseNCT01751672
Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
A study testing SBIRT and SBIRT+ in people with Drug Use and Alcohol Use, run by Treatment Research Institute at 3 sites in United States.
Trial summary
The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to determine if an expanded SBIRT (SBIRT+) will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use, Alcohol Use
- What is being tested?
- SBIRT and SBIRT+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to May 2015
- 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
- patient is 18 years or older
- Alcohol and/or Drug screening score that indicates at least mild problem severity.
Who cannot join
- medical or psychiatric complications
- substance use is mild enough that further intervention is not warranted
- patient reports plans to leave the area within the next 12 months
- patient is unable to provide valid informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eleventh Street Family Health Services of Drexel University
Philadelphia, Pennsylvania, 19123
Public Health Management Corporation's Care Clinic
Philadelphia, Pennsylvania, 19123
Abbottsford-Falls Family Practice, Resources for Human Development, Inc.
Philadelphia, Pennsylvania, 19144
About this study
The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to determine if an expanded SBIRT (SBIRT+) will help patients attend more specialty substance abuse treatment sessions and reduce substance use compared to SBIRT; 3) conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts; and 4) provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University.
Read the detailed description
This project has several specific aims. First, investigators plan to implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia, and to train three Behavioral Health Consultants (BHCs) in an expanded brief intervention protocol (SBIRT+). Second, investigators will conduct a randomized controlled trial to address the following hypotheses: 1) patients assigned to SBIRT+ will attend more specialty substance abuse intervention and treatment sessions (excluding SBIRT+ sessions) over the 12 month follow-up than patients assigned to SBIRT; 2) patients assigned to SBIRT+ will demonstrate larger reductions in drug use by point prevalence urine samples and by reported days using over the 12-month follow-up compared to patients in SBIRT; 3) SBIRT+ will have positive net social benefits relative to SBIRT alone (i.e., will be cost-effective); 4) patients assigned to SBIRT+ will demonstrate improved medical, employment, legal, and psychiatric functioning, as well as reduced HIV risk over the 12-month follow-up compared to patients in SBIRT. Thirdly, investigators will also determine whether SBIRT and SBIRT+ are sustainable in primary care clinics as research funding for behavioral health consultants is phased out in Year 4 of the project. Investigators will also conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts. This will inform methods to further disseminate SBIRT or SBIRT+, should the trial prove it is sustainable and cost-effective. Finally, investigators will provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University; this experience will balance hands-on clinical data collection and didactic training.
- Conditions
- Drug Use, Alcohol Use
- Being tested
- SBIRT, SBIRT+
- Keywords
- SBIRT, Substance Use, Screening, Brief Intervention, Primary Care
- Medical subject headings
- Alcohol Drinking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRTBehavioural
Screening, Brief Intervention, and Referral to Treatment. Standard, single session SBIRT.
SBIRT+Behavioural
Expanded Screening, Brief Intervention, and Referral to Treatment. One Standard SBIRT session, plus 2-6 additional Brief Intervention sessions as needed.
| Study group | Role | What they receive |
|---|---|---|
| SBIRT | Active comparator | Screening, Brief Intervention, and Referral to Treatment Receives: Behavioral: SBIRT |
| SBIRT+ | Experimental | Expanded Screening, Brief Intervention, and Referral to Treatment Receives: Behavioral: SBIRT+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treatment Session Attendance from Baseline
Treatment sessions attended for alcohol or drug use issues over time.
Measured: 0, 3, 6, 9, 12 months
Secondary outcomes (2)
Change in Urinalysis from Baseline
Urinalysis results for cocaine, marijuana, opiates, sedatives, and hallucinogens over time.
Measured: 0, 3, 6, 9, 12 months
Change in Cost-Effectiveness from Baseline
Cost-effectiveness of the interventions compared to standard care over time.
Measured: 0, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionMay 2015
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 Drug UseStudies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Adam C Brooks, PhD, Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751672
- Sponsor's protocol ID
- SAP No. 4100055578
- Other IDs
- 09-07-05
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2012
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chambers JE, Brooks AC, Medvin R, Metzger DS, Lauby J, Carpenedo CM, Favor KE, Kirby KC. Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial. Addict Sci Clin Pract. 2016 Apr 18;11(1):8. doi: 10.1186/s13722-016-0057-6.
PubMed 27090097
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Substance Abuse Assessment & Intervention in Primary Care Settings
- ClinicalTrials.gov ID
- NCT01751672
- Acronym / sponsor ID
- SAP No. 4100055578
- Conditions
- Drug Use, Alcohol Use
- Keywords
- SBIRT, Substance Use, Screening, Brief Intervention, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Dec 2012 (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.
The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to determine if an expanded SBIRT (SBIRT+) will help patients attend more specialty substance abuse treatment sessions and reduce substance use compared to SBIRT; 3) conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts; and 4) provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University.
Detailed description
This project has several specific aims. First, investigators plan to implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia, and to train three Behavioral Health Consultants (BHCs) in an expanded brief intervention protocol (SBIRT+). Second, investigators will conduct a randomized controlled trial to address the following hypotheses: 1) patients assigned to SBIRT+ will attend more specialty substance abuse intervention and treatment sessions (excluding SBIRT+ sessions) over the 12 month follow-up than patients assigned to SBIRT; 2) patients assigned to SBIRT+ will demonstrate larger reductions in drug use by point prevalence urine samples and by reported days using over the 12-month follow-up compared to patients in SBIRT; 3) SBIRT+ will have positive net social benefits relative to SBIRT alone (i.e., will be cost-effective); 4) patients assigned to SBIRT+ will demonstrate improved medical, employment, legal, and psychiatric functioning, as well as reduced HIV risk over the 12-month follow-up compared to patients in SBIRT. Thirdly, investigators will also determine whether SBIRT and SBIRT+ are sustainable in primary care clinics as research funding for behavioral health consultants is phased out in Year 4 of the project. Investigators will also conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts. This will inform methods to further disseminate SBIRT or SBIRT+, should the trial prove it is sustainable and cost-effective. Finally, investigators will provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University; this experience will balance hands-on clinical data collection and didactic training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBIRT | Active comparator | Behavioral: SBIRTScreening, Brief Intervention, and Referral to Treatment |
| SBIRT+ | Experimental | Behavioral: SBIRT+Expanded Screening, Brief Intervention, and Referral to Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient is 18 years or older
- Alcohol and/or Drug screening score that indicates at least mild problem severity.
Key exclusion criteria (4 listed)
- medical or psychiatric complications
- substance use is mild enough that further intervention is not warranted
- patient reports plans to leave the area within the next 12 months
- patient is unable to provide valid informed consent
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 |
|---|---|---|
| SBIRTScreening, Brief Intervention, and Referral to Treatment. Standard, single session SBIRT. | Behavioural | SBIRT |
| SBIRT+Expanded Screening, Brief Intervention, and Referral to Treatment. One Standard SBIRT session, plus 2-6 additional Brief Intervention sessions as needed. | Behavioural | SBIRT+ |
Primary outcome
Change in Treatment Session Attendance from Baseline
Time frame: 0, 3, 6, 9, 12 months
Treatment sessions attended for alcohol or drug use issues over time.
2 secondary outcomes
Change in Urinalysis from Baseline
Time frame: 0, 3, 6, 9, 12 months
Change in Cost-Effectiveness from Baseline
Time frame: 0, 3, 6, 9, 12 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 28 Mar 2023.
- Derived from this study: PubMed 27090097Chambers JE, Brooks AC, Medvin R, Metzger DS, Lauby J, Carpenedo CM, Favor KE, Kirby KC. Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial. Addict Sci Clin Pract. 2016 Apr 18;11(1):8. doi: 10.1186/s13722-016-0057-6.
Related trials for Drug Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
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.
Adam C Brooks, PhD principal investigator
Treatment Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT and SBIRT+ in people with Drug Use and Alcohol Use, run by Treatment Research Institute at 3 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 2 inclusion and 4 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Change in Treatment Session Attendance from Baseline (time frame: 0, 3, 6, 9, 12 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 NCT01751672, 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 28 Mar 2023.