Trial Outcomes & Findings for Safety & Prevention Outcomes Study (NCT NCT01894087)
NCT ID: NCT01894087
Last Updated: 2018-01-19
Results Overview
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.
COMPLETED
NA
204 participants
6 months post-baseline
2018-01-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
96
|
102
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Prevention Outcomes Study
Baseline characteristics by cohort
| Measure |
Therapist-led Brief Intervention With Enhanced Usual Care
n=102 Participants
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.
|
Enhanced Usual Care Only
n=102 Participants
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.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
36.1 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
36.8 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
22 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other/Missing/More than 1
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
102 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months post-baselinePopulation: Participants who were retained at follow-up and had complete data for all items for this measure at baseline and follow-up
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.
Outcome measures
| Measure |
Therapist-led Brief Intervention With Enhanced Usual Care
n=92 Participants
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.
|
Enhanced Usual Care Only
n=80 Participants
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.
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|---|---|---|
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Overdose Risk Behavior
|
-1.54 Scores on a scale
Interval -2.57 to -0.52
|
-0.51 Scores on a scale
Interval -1.75 to 0.72
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PRIMARY outcome
Timeframe: 6 months post-baselinePopulation: Participants retained and follow-up and with complete data on the outcome measure items at baseline and follow-up.
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.
Outcome measures
| Measure |
Therapist-led Brief Intervention With Enhanced Usual Care
n=91 Participants
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.
|
Enhanced Usual Care Only
n=81 Participants
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.
|
|---|---|---|
|
Overdose Knowledge
|
0.12 Scores on a scale
Interval -0.12 to 0.36
|
-0.11 Scores on a scale
Interval -0.41 to 0.18
|
PRIMARY outcome
Timeframe: 6 months post-baselinePopulation: Participants retained at follow-up and with complete item data on the outcome at baseline and follow-up
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.
Outcome measures
| Measure |
Therapist-led Brief Intervention With Enhanced Usual Care
n=88 Participants
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.
|
Enhanced Usual Care Only
n=80 Participants
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.
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|---|---|---|
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Behavioral Intentions
Use opioids as prescribed
|
8.0 Scores on a scale
Interval 7.4 to 8.6
|
8.4 Scores on a scale
Interval 7.8 to 8.9
|
|
Behavioral Intentions
Reducing or avoiding all use
|
8.1 Scores on a scale
Interval 7.5 to 8.6
|
7.0 Scores on a scale
Interval 6.3 to 7.8
|
|
Behavioral Intentions
Avoid combining substances
|
8.7 Scores on a scale
Interval 8.2 to 9.3
|
8.6 Scores on a scale
Interval 8.0 to 9.2
|
SECONDARY outcome
Timeframe: 6 months post-baselinePopulation: Participants retained at follow-up and with complete item data on this measure at both baseline and follow-up
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.
Outcome measures
| Measure |
Therapist-led Brief Intervention With Enhanced Usual Care
n=87 Participants
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.
|
Enhanced Usual Care Only
n=76 Participants
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.
|
|---|---|---|
|
Substance Use - Current Opioid Misuse Measure
|
-4.44 Scores on a scale
Interval -6.41 to -2.47
|
-3.54 Scores on a scale
Interval -5.84 to -1.24
|
Adverse Events
Therapist-led Brief Intervention With Enhanced Usual Care
Enhanced Usual Care Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place