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Trial · NCT01788306

Registered outcomes28

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of Fatal Opioid OverdoseOne yearRate of fatal opioid overdose
PrimaryRate of Non-fatal Opioid OverdoseOne yearRate of non-fatal opioid overdose
PrimaryElapsed Time Until Opioid OverdoseUp to1064 daysElapsed time until opioid overdose
PrimaryChange in Overdose Risk (Change in Opioid Use - Heroin)3 months
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)
PrimaryChange in Overdose Risk (Change in Opioid Use - Prescription-Type Opioids)3 months
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)
PrimaryChange in Overdose Risk (Using Alone When Taking Opioids)3 months
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes means at 3 month follow-up.)
PrimaryChange in Overdose Risk (Use of Sedatives When Taking Opioids)3 months
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use. (Data table includes proportions at 3 month follow-up.)
PrimaryChange in Overdose Risk (Use of Alcohol When Taking Opioids)3 months
Determine whether changes in behavior occur that increase or decrease risk of future overdose. Behaviors being measured include the amount of opioids taken, the use of opioids alone, use of opioids with alcohol or other drugs or medications, possessing naloxone, use of opioids in an environment that supports continued opioid use.(Data table includes proportions at 3 month follow-up.)
SecondaryHealth Care Utilization (ED and Inpatient Admissions)One year (annual rate)Appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care)
SecondaryChange in HIV Risk Behaviors (Condom Use)3 months
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV.(Data table includes proportions at 3 month follow-up.)
SecondaryChange in HIV Risk Behaviors (Shared Syringes)3 months
Determine whether change occurs in the number of sexual risk behaviors (such as engaging in intercourse without a condom) and/or injection use behaviors (such as sharing syringes) that may increase the risk of contracting HIV. (Data table includes proportions at 3 month follow-up.)
SecondaryChange in Overdose Risk Behaviors and Perceptions (Take Home Naloxone)3 MonthsChange in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
SecondaryChange in Overdose Risk Behaviors and Perceptions (Likelihood of Overdose)3 MonthsChange in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
SecondaryChange in Overdose Risk Behaviors and Perceptions (Concerned About Overdose)3 MonthsChange in overdose response including naloxone availability and change in overdose risk perceptions. (Data table includes proportions at 3 month follow-up.)
SecondarySubgroup Analyses - Change in HIV Risk Behaviors (Condom Use)3 monthsSub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
SecondarySubgroup Analyses - Change in HIV Risk Behaviors (Shared Syringes)3 monthsSub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
SecondarySub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Heroin)3 monthsSub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
SecondarySub-group Analyses - Change in Overdose Risk (Change in Opioid Use - Prescription Type Opioids)3 monthsSub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)
SecondarySub-group Analyses - Change in Overdose Risk (Using Alone When Taking Opioids)3 monthsSub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes means at 3 month follow-up.)
SecondarySubgroup Analyses- Change in Overdose Risk (Use of Sedatives When Taking Opioids)3 monthsSub-group analyses- primary and secondary outcomes will be examined by homelessness status at baseline.(Data table includes proportions at 3 month follow-up.)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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