Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01894087
Other study ID # R49CE002099
Secondary ID
Status Completed
Phase N/A
First received July 2, 2013
Last updated May 31, 2017
Start date April 2013
Est. completion date January 2015

Study information

Verified date May 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Unintentional poisoning is a developing public health problem in the U.S. Unintentional poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. There were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related overdoses, particularly prescription opioid overdoses, have accounted for much of this increase. There have been parallel increases in sales of opioids (with a 6 fold increase between 1997 and 2007), as well as both medical and non-medical use of prescription opioids. Prescription opioids are now among the most common of drugs used non-medically in the U.S.

The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription opioid overdose prevention intervention. We will examine therapeutic alliance, perceived satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on precursors of overdose risk behavioral change immediately post-intervention. We will compare intervention and control participants on knowledge, self-efficacy, readiness to change, and behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects on overdose risk behaviors six months post-intervention. We will compare intervention and control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and sedatives); and, 3) route of administration.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- patients 18-60 presenting to the ED for medical care

- ability to provide informed consent

- Additional criteria for intervention: past extramedical opioid use

Exclusion Criteria:

- patients who do not understand English

- prisoners

- patients classified by medical staff as a "Level 1" trauma (e.g., in need of immediate lifesaving procedures)

- patients deemed unable to provide informed consent

- patients treated in the ED for suicide attempt or sexual assault

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TBI - Cohort 1

TBI - Cohort 2


Locations

Country Name City State
United States University of Michigan Health System Emergency Department Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overdose Risk Behavior This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 28 in one assessment. Results reported here as group means are for the change in sum score between baseline and follow-up, which had a possible range of -28 to 28, with lower values indicating greater decreases in overdose risk behavior. 6 months post-baseline
Primary Overdose Knowledge Overdose symptom knowledge was assessed using an inventory of 5 true symptoms and 2 false symptoms of overdose, and the total score created as the sum of correct answers, with a range of 0 to 7. Due to the skewed distribution, this total score was standardized by subtracting the observed responses from the overall sample mean, and then dividing by the standard deviation. This resulted in a range of -5.4 to 2.6 in this sample at the 6 month follow-up, with higher numbers indicating greater overdose symptom knowledge. Also reported here are change scores generated by subtracting the standardized sum score at 6 months from the baseline standardized sum score, which had a range of -3.0 to 6.4 in this sample. Thus, higher numbers in this "change" variable indicated greater improvements in overdose symptom knowledge. Negative numbers would represent a decrease in symptom knowledge. 6 months post-baseline
Primary Behavioral Intentions Behavioral intentions were assessed with three items that measured participant's intention to use overdose risk reduction strategies. The three strategies were (1) using opioids as prescribed, (2) reducing or avoiding use of alcohol, drugs, or non-prescribed medications, and (3) avoiding combining substances. Each item was assessed on a scale of 1 to 10, with higher numbers indicating greater intention to avoid overdose risk. 6 months post-baseline
Secondary Substance Use - Current Opioid Misuse Measure This measure contained 8 items from the Current Opioid Misuse Measure. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (3)," "often (4)," and "very often (5)." A sum score took a range of 0 to 40, with higher numbers indicating more non-medical opioid use. For group means reported here, change scores were calculated by subtracting the baseline level of this measure from the level at 6 months follow-up. This change score has a possible range of -40 to 40, with lower values indicating greater decreases in non-medical opioid use. 6 months post-baseline
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03950492 - Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder N/A
Completed NCT00000335 - Activity Monitoring Assessment of Opiate Withdrawal - 4 Phase 2
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Enrolling by invitation NCT06084221 - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems N/A
Completed NCT02978417 - Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings Phase 4
Withdrawn NCT03137030 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults Phase 1
Withdrawn NCT03137017 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT00710385 - Abuse Liability of Suboxone Versus Subutex Phase 3
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Completed NCT00218309 - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals Phase 2
Terminated NCT00000243 - Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone N/A
Completed NCT00067184 - Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Completed NCT00000264 - Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16 N/A
Completed NCT00000257 - Effects of Alcohol History on Effects of Nitrous Oxide - 9 N/A
Completed NCT00000279 - Novel Medications for Opiate Detoxification - 4 Phase 2
Completed NCT00000306 - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Phase 2
Completed NCT00000249 - Effects of Subanesthetic Concentrations of Nitrous Oxide - 1 Phase 2
Recruiting NCT04933084 - Pre-operative Education Modalities to Decrease Opioid Use N/A
Recruiting NCT03610672 - Mobile Intervention for Young Opioid Users N/A