Opioid Use DisorderNCT06311838
Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness
A study testing Motivational Interviewing/Community Reinforcement Approach (MI/CRA), Strengths-Based Outreach and Advocacy (SBOA ) and Services as Usual (SAU) in people with Opioid Use Disorder and Dual Diagnosis, run by Ohio State University at 2 sites in United States.
Trial summary
Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Opioid Use Disorder, Dual Diagnosis, Housing Problems
- What is being tested?
- Motivational Interviewing/Community Reinforcement Approach (MI/CRA), Strengths-Based Outreach and Advocacy (SBOA ) and Services as Usual (SAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 May 2024to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth must meet the criteria for homelessness as defined by the McKinney-Vento Act: children and youth who lack a fixed, regular, and adequate nighttime residence; or live in a welfare hotel, or place without regular sleeping accommodations, or live in a shared residence with other persons due to the loss of one's housing or economic hardship
- Must speak english adequately to complete measures
Who cannot join
- Youth who have a stable housing situation.
- Non-English speaker
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Star House
Columbus, Ohio, 43201
Natasha Slesnick, PhD, 614-247-8469, slesnick.5@osu.edu
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Jodi Ford, PhD, 614-292-6862, ford.553@osu.edu
Natasha Slesnick, PhD, (614) 247-8469, slesnick.5@osu.edu
About this study
Official title: Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness: An RCT Examining Biopsychosocial Mechanisms
Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.
Read the detailed description
Specific Aim 1. Using a dismantling randomized design, compare intervention conditions to determine those components essential for optimizing substance use and mental health: a) Strengths-Based Outreach and Advocacy (SBOA), b) Motivational Interviewing (MI)/Community Reinforcement Approach (CRA), c) SBOA+MI/CRA, and d) Services As Usual (SAU). Hypothesis. Youth assigned to SBOA+MI/CRA will show better short and long-term outcomes on Opioid Use Disorder prevention and on other substance use and mental health outcomes than youth assigned to either intervention alone or Services As Usual.
Specific Aim 2. Test whether intended change processes (social stability, psychosocial resources, stress) produce the desired change on substance use and mental health. Hypothesis. Inasmuch as the interventions trigger successful increases in social stability and psychosocial resources and reductions in stress, targeted outcomes will improve.
Specific Aim 3. Explore how the moderators of age, sex, race/ethnicity, sexual/gender minority status, and experience of childhood abuse and neglect influence intervention response.
Specific Aim 4. Determine cost effectiveness of the intervention approaches.
- Conditions
- Opioid Use Disorder, Dual Diagnosis, Housing Problems, Mental Disorder in Adolescence, Risk Behavior, Homelessness
- Being tested
- Motivational Interviewing/Community Reinforcement Approach (MI/CRA), Strengths-Based Outreach and Advocacy (SBOA ), Services as Usual (SAU)
- Keywords
- youth experiencing homelessness, social determinants of health, opioid use disorder, substance use
- Medical subject headings
- Opioid-Related Disorders, Risk-Taking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing/Community Reinforcement Approach (MI/CRA)Behavioural
MI/CRA includes two Motivational Interviewing sessions and twelve 1-hour Community Reinforcement Approach sessions.
Strengths-Based Outreach and Advocacy (SBOA )Behavioural
The number of Strengths-Based Outreach and Advocacy sessions participants will receive are flexibly determined based upon youth needs.
Services as Usual (SAU)Behavioural
Participants assigned to this group will receive the standard services provided to all youth involved with the drop-in center.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU) | Experimental | The current evidence base recommends integrating treatments targeting both Substance Use Disorder and psychiatric disorders, especially combining Motivational Interviewing with behavioral interventions such as CRA or Cognitive Behaviorial Therapy.
Enhancing intrinsic motivation for behavioral change is the central purpose of motivational interviewing (MI), a clinical method built on the insights and strategies described by Carl Rogers as client-centered therapy. MI is also directive, however, in selectively eliciting and reinforcing client "change talk". Typically offered as a brief intervention of 1-2 sessions, MI has a strong record of efficacy in the treatment of alcohol and other drug use disorders, mental health and other problematic behaviors.
The Community Reinforcement Approach (CRA) offers an empirically-based multifaceted approach to substance abuse/mental health treatment that also addresses many of the clinical needs of multi-problem homeless individuals. Receives: Behavioral: Motivational Interviewing/Community Reinforcement Approach (MI/CRA); Behavioral: Services as Usual (SAU) |
| Strengths-Based Outreach and Advocacy + Services As Usual (SBOA +SAU) | Experimental | Some research suggests that engagement with an advocate is key to success when linking those experiencing homelessness to available services and supports in the community. The strengths model is based on the premise that the purpose of advocacy "is to assist consumers in identifying, securing, and preserving the range of resources, both external and internal, needed to live in a normal, independent way in the community". Strengths-based interventions focus on enhancing well-being and happiness rather than attempting to correct deficits or pathology. The advocate takes responsibility for securing needed services for the youth and remains a support as they traverse the system of care. The focus of the first several weeks of advocacy is on obtaining identification and ensuring basic needs are met (food, safety, medical care, housing, etc.). As basic needs are addressed, youth and advocates focus on other high need areas including education, employment, mental health and substance use. Receives: Behavioral: Strengths-Based Outreach and Advocacy (SBOA ); Behavioral: Services as Usual (SAU) |
| Motivational Interviewing/Community Reinforcement Approach (MI/CRA) + SBOA + SAU | Experimental | This intervention combines all three interventional models: Motivational Interviewing/Community Reinforcement Approach along with Strengths-Based Outreach and Advocacy and the Services as Usual. Receives: Behavioral: Motivational Interviewing/Community Reinforcement Approach (MI/CRA); Behavioral: Strengths-Based Outreach and Advocacy (SBOA ); Behavioral: Services as Usual (SAU) |
| Services as Usual (SAU) | Active comparator | All youth will receive services as usual provided by the drop-in center. Receives: Behavioral: Services as Usual (SAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Form 90 Substance Use interview
Self-reported interviewer-administered Form 90 Substance Use interview developed for National Institute on Alcohol Abuse and Alcoholism (NIAAA) funded Project Match. The Form 90 differentiates illicit drug use from prescribed drug use including marijuana.
Measured: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD)
The SIP-AD measures consequences related to impulse control and social responsibility, as well as physical, interpersonal, and intrapersonal domains with good psychometric properties.
Measured: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Presence of drugs of abuse
One-step BMC ToxCup® Urine Test Kit Provides instant reading urine test for the presence or lack of detection of cannabinoids, amphetamines, methamphetamines, phencyclidine (PCP), cocaine/crack, and opiates. (Branan Medical Corp., Irvine, CA).
Detection levels:
Marijuana 50 ng/ml Cocaine 150 ng/ml Opiates 300 ng/ml Methamphetamine 500 ng/ml Ecstasy 500 ng/ml Phencyclidine 25 ng/ml Propoxyphene 300 ng/ml Benzodiazepines 300 ng/ml Barbiturates 300 ng/ml Methadone 300 ng/ml Buprenorphine 10 ng/ml Tricyclic Antidepressants 1000 ng/ml Oxycodone 100 ng/ml
Measured: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Beck Depression Inventory II (BDI-II)
The most frequently used self-report instrument to assess mood, cognitive and somatic aspects of depression. The BDI-II has good psychometric properties. Scores range from 0 - 63 with higher scores indicating more depressived symptoms and worse outcomes.
Measured: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Beck Anxiety Inventory (BAI)
Used to assess current anxiety symptoms via 21 items, rated in intensity with scores ranging from 0-63. It was developed to discriminate symptoms of anxiety from depressive symptoms, and has alpha coefficients ranging from 0.90-0.94. Higher scores indicate more anxiety symptoms and worse outcomes.
Measured: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Short Form-12
Standardized, internationally used instrument that provides a general measure of health status.The 12 items on the SF-12 are summarized in two weighted summary scales, and generate a mental health and physical health score. Scores range from 1 -100. Lower scores indicate poorer health. Construct validity has been evaluated with adult users of a homeless day shelter
Measured: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start6 May 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
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 Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a dismantling, randomized controlled design, researchers will examine the singular and combined impact of Motivational Interviewing/Community Reinforcement Approach (MI/CRA) and Strengths-Based Outreach and Advocacy (SBOA) on substance use, mental health and other outcomes (e.g., housing stability, education, employment) with Youth Experiencing Homelessness (YEH) recruited from a local drop-in center.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311838
- Sponsor's protocol ID
- 2023H0244
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research for public-use data sharing will include three data types: survey data, stress biomarker data, and activity-space data. The final survey dataset will include self-reported demographic, behavioral, social (e.g. exposures to adversity, including homelessness, violence, incarceration, etc.) and health-related data (e.g. psychosocial measures, mental and physical health symptoms/disorders and diagnoses, health services). The data will be deposited with the Inter-University Consortium for Political and Social Research (ICPSR), an NIH funded data repository supported by National Institute on Drug Abuse as a data repository. The data from all 300 participants will be available for the six time-points of collection, made available in ICPSR preferred formats (e.g., CSV, SAS, SPSS) and securely transferred to ICPSR. Identifying (individual and location data) and personal health information will NOT be shared to protect participant confidentiality.
Publications
Ford J, Slesnick N, Browning C, Feng X, Yilmazer T, Boettner B, Luthy J, Fitzpatrick M, Pinkus L, Holowacz E, Hang C. Building social and structural connections for the prevention of opioid use among youth experiencing homelessness: study protocol for a randomized controlled trial. BMC Public Health. 2026 Jul 15. doi: 10.1186/s12889-026-28177-4. Online ahead of print.
PubMed 42449276
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness: An RCT Examining Biopsychosocial Mechanisms
- ClinicalTrials.gov ID
- NCT06311838
- Acronym / sponsor ID
- 2023H0244
- Conditions
- Opioid Use Disorder, Dual Diagnosis, Housing Problems, Mental Disorder in Adolescence, Risk Behavior, Homelessness
- Keywords
- youth experiencing homelessness, social determinants of health, opioid use disorder, substance use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 15 Mar 2024 (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.
Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.
Detailed description
Specific Aim 1. Using a dismantling randomized design, compare intervention conditions to determine those components essential for optimizing substance use and mental health: a) Strengths-Based Outreach and Advocacy (SBOA), b) Motivational Interviewing (MI)/Community Reinforcement Approach (CRA), c) SBOA+MI/CRA, and d) Services As Usual (SAU). Hypothesis. Youth assigned to SBOA+MI/CRA will show better short and long-term outcomes on Opioid Use Disorder prevention and on other substance use and mental health outcomes than youth assigned to either intervention alone or Services As Usual.
Specific Aim 2. Test whether intended change processes (social stability, psychosocial resources, stress) produce the desired change on substance use and mental health. Hypothesis. Inasmuch as the interventions trigger successful increases in social stability and psychosocial resources and reductions in stress, targeted outcomes will improve.
Specific Aim 3. Explore how the moderators of age, sex, race/ethnicity, sexual/gender minority status, and experience of childhood abuse and neglect influence intervention response.
Specific Aim 4. Determine cost effectiveness of the intervention approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Using a dismantling, randomized controlled design, researchers will examine the singular and combined impact of Motivational Interviewing/Community Reinforcement Approach (MI/CRA) and Strengths-Based Outreach and Advocacy (SBOA) on substance use, mental health and other outcomes (e.g., housing stability, education, employment) with Youth Experiencing Homelessness (YEH) recruited from a local drop-in center.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU) | Experimental | Behavioral: Motivational Interviewing/Community Reinforcement Approach (MI/CRA), Behavioral: Services as Usual (SAU)The current evidence base recommends integrating treatments targeting both Substance Use Disorder and psychiatric disorders, especially combining Motivational Interviewing with behavioral interventions such as CRA or Cognitive Behaviorial Therapy. Enhancing intrinsic motivation for behavioral change is the central purpose of motivational interviewing (MI), a clinical method built on the insights and strategies described by Carl Rogers as client-centered therapy. MI is also directive, however, in selectively eliciting and reinforcing client "change talk". Typically offered as a brief intervention of 1-2 sessions, MI has a strong record of efficacy in the treatment of alcohol and other drug use disorders, mental health and other problematic behaviors. The Community Reinforcement Approach (CRA) offers an empirically-based multifaceted approach to substance abuse/mental health treatment that also addresses many of the clinical needs of multi-problem homeless individuals. |
| Strengths-Based Outreach and Advocacy + Services As Usual (SBOA +SAU) | Experimental | Behavioral: Strengths-Based Outreach and Advocacy (SBOA ), Behavioral: Services as Usual (SAU)Some research suggests that engagement with an advocate is key to success when linking those experiencing homelessness to available services and supports in the community. The strengths model is based on the premise that the purpose of advocacy "is to assist consumers in identifying, securing, and preserving the range of resources, both external and internal, needed to live in a normal, independent way in the community". Strengths-based interventions focus on enhancing well-being and happiness rather than attempting to correct deficits or pathology. The advocate takes responsibility for securing needed services for the youth and remains a support as they traverse the system of care. The focus of the first several weeks of advocacy is on obtaining identification and ensuring basic needs are met (food, safety, medical care, housing, etc.). As basic needs are addressed, youth and advocates focus on other high need areas including education, employment, mental health and substance use. |
| Motivational Interviewing/Community Reinforcement Approach (MI/CRA) + SBOA + SAU | Experimental | Behavioral: Motivational Interviewing/Community Reinforcement Approach (MI/CRA), Behavioral: Strengths-Based Outreach and Advocacy (SBOA ), Behavioral: Services as Usual (SAU)This intervention combines all three interventional models: Motivational Interviewing/Community Reinforcement Approach along with Strengths-Based Outreach and Advocacy and the Services as Usual. |
| Services as Usual (SAU) | Active comparator | Behavioral: Services as Usual (SAU)All youth will receive services as usual provided by the drop-in center. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Youth must meet the criteria for homelessness as defined by the McKinney-Vento Act: children and youth who lack a fixed, regular, and adequate nighttime residence; or live in a welfare hotel, or place without regular sleeping accommodations, or live in a shared residence with other persons due to the loss of one's housing or economic hardship
- Must speak english adequately to complete measures
Key exclusion criteria (2 listed)
- Youth who have a stable housing situation.
- Non-English speaker
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 |
|---|---|---|
| Motivational Interviewing/Community Reinforcement Approach (MI/CRA)MI/CRA includes two Motivational Interviewing sessions and twelve 1-hour Community Reinforcement Approach sessions. | Behavioural | Motivational Interviewing/Community Reinforcement Approach (MI/CRA) + SBOA + SAU, Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU) |
| Strengths-Based Outreach and Advocacy (SBOA )The number of Strengths-Based Outreach and Advocacy sessions participants will receive are flexibly determined based upon youth needs. | Behavioural | Motivational Interviewing/Community Reinforcement Approach (MI/CRA) + SBOA + SAU, Strengths-Based Outreach and Advocacy + Services As Usual (SBOA +SAU) |
| Services as Usual (SAU)Participants assigned to this group will receive the standard services provided to all youth involved with the drop-in center. | Behavioural | Motivational Interviewing/Community Reinforcement Approach (MI/CRA) + SBOA + SAU, Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU), Services as Usual (SAU), Strengths-Based Outreach and Advocacy + Services As Usual (SBOA +SAU) |
Primary outcome
Form 90 Substance Use interview
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Self-reported interviewer-administered Form 90 Substance Use interview developed for National Institute on Alcohol Abuse and Alcoholism (NIAAA) funded Project Match. The Form 90 differentiates illicit drug use from prescribed drug use including marijuana.
Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD)
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
The SIP-AD measures consequences related to impulse control and social responsibility, as well as physical, interpersonal, and intrapersonal domains with good psychometric properties.
Presence of drugs of abuse
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
One-step BMC ToxCup® Urine Test Kit Provides instant reading urine test for the presence or lack of detection of cannabinoids, amphetamines, methamphetamines, phencyclidine (PCP), cocaine/crack, and opiates. (Branan Medical Corp., Irvine, CA). Detection levels: Marijuana 50 ng/ml Cocaine 150 ng/ml Opiates 300 ng/ml Methamphetamine 500 ng/ml Ecstasy 500 ng/ml Phencyclidine 25 ng/ml Propoxyphene 300 ng/ml Benzodiazepines 300 ng/ml Barbiturates 300 ng/ml Methadone 300 ng/ml Buprenorphine 10 ng/ml Tricyclic Antidepressants 1000 ng/ml Oxycodone 100 ng/ml
Beck Depression Inventory II (BDI-II)
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
The most frequently used self-report instrument to assess mood, cognitive and somatic aspects of depression. The BDI-II has good psychometric properties. Scores range from 0 - 63 with higher scores indicating more depressived symptoms and worse outcomes.
Beck Anxiety Inventory (BAI)
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Used to assess current anxiety symptoms via 21 items, rated in intensity with scores ranging from 0-63. It was developed to discriminate symptoms of anxiety from depressive symptoms, and has alpha coefficients ranging from 0.90-0.94. Higher scores indicate more anxiety symptoms and worse outcomes.
Short Form-12
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Standardized, internationally used instrument that provides a general measure of health status.The 12 items on the SF-12 are summarized in two weighted summary scales, and generate a mental health and physical health score. Scores range from 1 -100. Lower scores indicate poorer health. Construct validity has been evaluated with adult users of a homeless day shelter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 42449276Ford J, Slesnick N, Browning C, Feng X, Yilmazer T, Boettner B, Luthy J, Fitzpatrick M, Pinkus L, Holowacz E, Hang C. Building social and structural connections for the prevention of opioid use among youth experiencing homelessness: study protocol for a randomized controlled trial. BMC Public Health. 2026 Jul 15. doi: 10.1186/s12889-026-28177-4. Online ahead of print.
- Individual participant dataSharing planned: Yes. The proposed research for public-use data sharing will include three data types: survey data, stress biomarker data, and activity-space data. The final survey dataset will include self-reported demographic, behavioral, social (e.g. exposures to adversity, including homelessness, violence, incarceration, etc.) and health-related data (e.g. psychosocial measures, mental and physical health symptoms/disorders and diagnoses, health services). The data will be deposited with the Inter-University Consortium for Political and Social Research (ICPSR), an NIH funded data repository supported by National Institute on Drug Abuse as a data repository. The data from all 300 participants will be available for the six time-points of collection, made available in ICPSR preferred formats (e.g., CSV, SAS, SPSS) and securely transferred to ICPSR. Identifying (individual and location data) and personal health information will NOT be shared to protect participant confidentiality.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing/Community Reinforcement Approach (MI/CRA), Strengths-Based Outreach and Advocacy (SBOA ) and Services as Usual (SAU) in people with Opioid Use Disorder and Dual Diagnosis, run by Ohio State 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 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodi Ford, PhD (614-292-6862, ford.553@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Form 90 Substance Use interview (time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.). The study lists 6 primary outcomes in all. 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 NCT06311838, 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 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.