Drug Overdose, Opioid-Related Disorders
Conditions
Brief 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.
Interventions
BEHAVIORALTBI - Cohort 1
BEHAVIORALTBI - Cohort 2
Sponsors
Centers for Disease Control and Prevention
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overdose Risk Behavior | 6 months post-baseline | 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. |
| Overdose Knowledge | 6 months post-baseline | 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. |
| Behavioral Intentions | 6 months post-baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance Use - Current Opioid Misuse Measure | 6 months post-baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Therapist-led Brief Intervention With Enhanced Usual Care Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a change plan for each participant. Participants in this condition also received the brochures given for the Enhanced Usual Care protocol. | 102 |
| Enhanced Usual Care Only For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline. | 102 |
| Total | 204 |
Baseline characteristics
| Characteristic | Enhanced Usual Care Only | Therapist-led Brief Intervention With Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 36.1 years STANDARD_DEVIATION 10.9 | 37.5 years STANDARD_DEVIATION 11.4 | 36.8 years STANDARD_DEVIATION 11.1 |
| Race/Ethnicity, Customized Black | 16 Participants | 22 Participants | 38 Participants |
| Race/Ethnicity, Customized Other/Missing/More than 1 | 7 Participants | 11 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 79 Participants | 69 Participants | 148 Participants |
| Region of Enrollment United States | 102 Participants | 102 Participants | 204 Participants |
| Sex: Female, Male Female | 69 Participants | 61 Participants | 130 Participants |
| Sex: Female, Male Male | 33 Participants | 41 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 102 | 0 / 102 |
| other Total, other adverse events | 0 / 102 | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 | 0 / 102 |
Outcome results
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.
Time frame: 6 months post-baseline
Population: Participants retained at follow-up and with complete item data on the outcome at baseline and follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Therapist-led Brief Intervention With Enhanced Usual Care | Behavioral Intentions | Use opioids as prescribed | 8.0 Scores on a scale |
| Therapist-led Brief Intervention With Enhanced Usual Care | Behavioral Intentions | Reducing or avoiding all use | 8.1 Scores on a scale |
| Therapist-led Brief Intervention With Enhanced Usual Care | Behavioral Intentions | Avoid combining substances | 8.7 Scores on a scale |
| Enhanced Usual Care Only | Behavioral Intentions | Use opioids as prescribed | 8.4 Scores on a scale |
| Enhanced Usual Care Only | Behavioral Intentions | Reducing or avoiding all use | 7.0 Scores on a scale |
| Enhanced Usual Care Only | Behavioral Intentions | Avoid combining substances | 8.6 Scores on a scale |
Comparison: Multivariable Poisson regression of the outcome of intention to use opioids as prescribed, adjusting for baseline level of the outcome.95% CI: [0.93, 1.33]
Comparison: Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome.95% CI: [0.65, 0.9]
Comparison: Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome.95% CI: [0.8, 1.19]
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.
Time frame: 6 months post-baseline
Population: Participants retained and follow-up and with complete data on the outcome measure items at baseline and follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapist-led Brief Intervention With Enhanced Usual Care | Overdose Knowledge | 0.12 Scores on a scale |
| Enhanced Usual Care Only | Overdose Knowledge | -0.11 Scores on a scale |
Comparison: Multivariable linear regression of the outcome of standardized sum score of overdose symptom knowledge at 6 months follow-up, adjusted for baseline level of overdose symptom knowledge.95% CI: [-0.2, 0.4]
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.
Time frame: 6 months post-baseline
Population: Participants who were retained at follow-up and had complete data for all items for this measure at baseline and follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapist-led Brief Intervention With Enhanced Usual Care | Overdose Risk Behavior | -1.54 Scores on a scale |
| Enhanced Usual Care Only | Overdose Risk Behavior | -0.51 Scores on a scale |
Comparison: Multivariable Poisson regression of outcome of overdose risk behavior sum score at 6 months, adjusting for baseline level of the outcome95% CI: [0.59, 0.87]
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.
Time frame: 6 months post-baseline
Population: Participants retained at follow-up and with complete item data on this measure at both baseline and follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapist-led Brief Intervention With Enhanced Usual Care | Substance Use - Current Opioid Misuse Measure | -4.44 Scores on a scale |
| Enhanced Usual Care Only | Substance Use - Current Opioid Misuse Measure | -3.54 Scores on a scale |
Comparison: Multivariable Poisson regression for the outcome of total COMM score at follow-up, adjusting for baseline level of the outcome95% CI: [0.7, 0.92]