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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA040862 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This project will further develop and test the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO (NCT02282306) found that the participating patients and the Peer Interventionists were satisfied with their participation, the intervention was acceptable, and the system for generating patient-tailored intervention information performed well. The overall goal of the present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control group. It is hypothesized that patients in the TTIP-PRO group will have more favorable drug-abuse-related outcomes than patients in the control group.
This pilot study is a randomized controlled intent-to-treat (ITT) clinical trial. Approximately eighty eligible participants will be randomized in a 1:1 ratio to the control condition (Information and NARCAN® (naloxone) Nasal Spray kit) or to the experimental condition (TTIP-PRO in addition to the elements provided in the control condition). All participants will complete a follow-up phone call approximately 3-weeks post-randomization, during which process measures will be completed, and in-person visits at approximately 3, 6-, and 12-months following enrollment.
This is a single site study; all data will be collected at the University of Cincinnati. Approximately 80 participants will be randomized into this pilot efficacy trial. The hypotheses to be tested include that participants assigned to the TTIP-PRO intervention will: have a higher rate of enrollment in MAT, have a lower rate of recurring opioid overdose, and have greater reduction in illicit opioid use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTOEND | Active Comparator | PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution. Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment. |
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| PTOEND+PI | Experimental | PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention. In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Intervention | Behavioral | The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. The primary goal of the call is for the participant and the Peer Interventionist to have an open exchange of information about medication-assisted treatment (MAT) for opioid use disorder. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication-Assisted Treatment Enrollment | whether or not participant enrolled in medication-assisted treatment within the follow-up period | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Overdose Experience | whether or not participant experienced an opioid overdose within the follow-up period period. | 12 months |
| Change in Opioid Use (Timeline Follow-back) | Difference in self-reported opioid use in the prior 28 days, from Baseline to 12-month visit, computed as: (12-month opioid use days - Baseline opioid use days); negative values indicate a reduction in self-reported opioid use days from Baseline to 12-month visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Winhusen, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Addiction Sciences Division | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34236298 | Derived | Kropp F, Wilder C, Theobald J, Lewis D, Winhusen TJ. The feasibility and safety of training patients in opioid treatment to serve as peer recovery support service interventionists. Subst Abus. 2022;43(1):527-530. doi: 10.1080/08897077.2021.1949667. Epub 2021 Jul 8. |
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Data will be shared in a timely manner, i.e., no later than the acceptance for publication of the main findings from the final dataset. The dataset will include information about illegal activities (e.g., illicit opioid use, etc.). Thus, in addition to only a de-identified database being shared, we will also require a data sharing agreement. The data sharing agreement will require commitment to: 1) not re-disclose the data; 2) secure the data; 3) use the data for research purposes only; 4) make no attempt to identify individual participants; 5) destroy the data once the planned research activities have been completed; 6) follow all relevant NIH policies.
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116 potential participants were consented and screened, and 80 were randomized to Personally-tailored opioid overdose education and naloxone distribution plus Peer Intervention (PTOEND+PI) (n=40) or PTOEND (n=40).
Potential participants were recruited through various methods including advertisements, flyers, and word-of-mouth. Greater than 90% of participants were recruited from a syringe exchange program. All participants were given a thorough explanation of the study and signed an informed consent form.
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| ID | Title | Description |
|---|---|---|
| FG000 | PTOEND | PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution. Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2018 | Jun 4, 2020 |
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| naloxone nasal spray kit | Drug | Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to the patient participants, which may be useful in the event of a future opioid overdose. |
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| Personally-tailored opioid overdose prevention education (information packet) | Behavioral | Personally-tailored information packet with three participant-specific reports ("Personal Overdose Risk Factors Report"; "Medication Assisted Treatment (MAT) Report"; and the "Opioid Overdose Information Report"), and general written information about opioid overdose and treatment for opioid use disorder. |
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| at 12-month visit |
| Change in Opioid Use (Urine Drug Screen) | Number of participants who provided an opioid-negative urine sample, assessed by a rapid urine drug screen system, at the 12-month visit. Results that were positive, but specific to only buprenorphine or methadone, were counted as negative for participants with verified enrollment in medication-assisted treatment. Note that all participants were required to have an opioid-positive urine sample at Baseline, in order to be eligible for the study. | at 12-month visit |
| FG001 | PTOEND+PI | PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention. In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention. Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. |
| 3 Weeks |
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| 3 Months |
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| 6 Months |
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| 12 Months |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PTOEND | PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution. Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. |
| BG001 | PTOEND+PI | PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention. In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention. Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication-Assisted Treatment Enrollment | whether or not participant enrolled in medication-assisted treatment within the follow-up period | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Opioid Overdose Experience | whether or not participant experienced an opioid overdose within the follow-up period period. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Change in Opioid Use (Timeline Follow-back) | Difference in self-reported opioid use in the prior 28 days, from Baseline to 12-month visit, computed as: (12-month opioid use days - Baseline opioid use days); negative values indicate a reduction in self-reported opioid use days from Baseline to 12-month visit. | Analysis could only be done on data provided by participants who attended the 12-month visit | Posted | Mean | Standard Deviation | days | at 12-month visit |
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| Secondary | Change in Opioid Use (Urine Drug Screen) | Number of participants who provided an opioid-negative urine sample, assessed by a rapid urine drug screen system, at the 12-month visit. Results that were positive, but specific to only buprenorphine or methadone, were counted as negative for participants with verified enrollment in medication-assisted treatment. Note that all participants were required to have an opioid-positive urine sample at Baseline, in order to be eligible for the study. | Analysis could only be done on samples provided by participants who attended the 12-month visit | Posted | Count of Participants | Participants | at 12-month visit |
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12 months. Adverse events were systematically assessed during each research visit.
Serious Adverse Events were defined as an event that results in any of the following outcomes: death, life threatening, requires hospitalization, initial or prolonged, results in disability, congenital anomaly, requires intervention to prevent permanent impairment or damage, or other significant medical event.
Other (non-Serious) adverse events were defined as suicidal ideation or homicidal ideation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | PTOEND | PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution. Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. | 0 | 40 | 9 | 40 | 0 | 40 |
| EG001 | PTOEND+PI | PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention. In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention. Peer Intervention: The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. naloxone nasal spray kit: Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. Personally-tailored opioid overdose prevention education (information packet): Personally-tailored information packet with three participant-specific reports and general written information about opioid overdose and treatment for opioid use disorder. | 0 | 40 | 7 | 40 | 0 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for musculoskeletal problem / injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | Systematic Assessment |
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| Congenital Anomaly or Birth Defect | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Hospitalization for nervous system disorder | Nervous system disorders | Systematic Assessment |
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| Hospitalization for renal disorder | Renal and urinary disorders | Systematic Assessment |
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| Hospitalization related to pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Hospitalization for infection/abscess | Infections and infestations | Systematic Assessment |
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| Hospitalization for psychiatric problem | Psychiatric disorders | Systematic Assessment |
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| Hospitalization for respiratory condition | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hospitalization for multiple causes | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa Winhusen | University of Cincinnati Addiction Sciences Division | 5135858292 | winhust@ucmail.uc.edu |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2017 | Jun 4, 2020 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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