Trial Outcomes & Findings for Harm Reduction With Pharmacotherapy (HaRP) (NCT NCT01932801)
NCT ID: NCT01932801
Last Updated: 2023-05-10
Results Overview
Using the Alcohol Quantity and Use Assessment, we will collect data on peak alcohol quantity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
308 participants
Primary outcome timeframe
Baseline, week 4, week 8, week 12, week 24, week 36
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
XR-NTX+HRC
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
Harm-reduction Counseling (HRC)
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
Assessment-only
Assessment-only control condition
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
78
|
79
|
77
|
|
Overall Study
Week 0 Session
|
67
|
66
|
71
|
65
|
|
Overall Study
Week 4 Session
|
54
|
54
|
60
|
41
|
|
Overall Study
Week 8 Session
|
51
|
48
|
56
|
42
|
|
Overall Study
Week 12 Session
|
56
|
50
|
55
|
40
|
|
Overall Study
Week 24 Session
|
49
|
46
|
53
|
40
|
|
Overall Study
Week 36 Session
|
48
|
48
|
54
|
40
|
|
Overall Study
COMPLETED
|
48
|
48
|
54
|
40
|
|
Overall Study
NOT COMPLETED
|
26
|
30
|
25
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Harm Reduction With Pharmacotherapy (HaRP)
Baseline characteristics by cohort
| Measure |
Assessment-only
n=77 Participants
Assessment-only control condition
|
HRC - Harm Reduction Counseling
n=79 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=74 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=78 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.51 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
49.38 years
STANDARD_DEVIATION 7.35 • n=7 Participants
|
49.27 years
STANDARD_DEVIATION 9.11 • n=5 Participants
|
46.55 years
STANDARD_DEVIATION 10.46 • n=4 Participants
|
48.17 years
STANDARD_DEVIATION 9.21 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
258 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
273 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4, week 8, week 12, week 24, week 36Using the Alcohol Quantity and Use Assessment, we will collect data on peak alcohol quantity.
Outcome measures
| Measure |
Assessment-only
n=77 Participants
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=79 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=74 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=78 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
|---|---|---|---|---|
|
Alcohol Quantity
Baseline
|
27.37 number of drinks on peak occasion
Standard Deviation 1.98
|
25.95 number of drinks on peak occasion
Standard Deviation 1.79
|
32.02 number of drinks on peak occasion
Standard Deviation 1.70
|
32.15 number of drinks on peak occasion
Standard Deviation 1.74
|
|
Alcohol Quantity
Week 4
|
22.4 number of drinks on peak occasion
Standard Deviation 2.23
|
18.97 number of drinks on peak occasion
Standard Deviation 2.76
|
18.18 number of drinks on peak occasion
Standard Deviation 2.41
|
21.33 number of drinks on peak occasion
Standard Deviation 2.32
|
|
Alcohol Quantity
Week 8
|
20.45 number of drinks on peak occasion
Standard Deviation 2.41
|
15.85 number of drinks on peak occasion
Standard Deviation 2.56
|
13.56 number of drinks on peak occasion
Standard Deviation 3.15
|
17.21 number of drinks on peak occasion
Standard Deviation 2.44
|
|
Alcohol Quantity
Week 12
|
16.80 number of drinks on peak occasion
Standard Deviation 3.16
|
12.92 number of drinks on peak occasion
Standard Deviation 3.18
|
12.81 number of drinks on peak occasion
Standard Deviation 3.3
|
19.09 number of drinks on peak occasion
Standard Deviation 2.28
|
|
Alcohol Quantity
Week 24
|
16.77 number of drinks on peak occasion
Standard Deviation 3.36
|
13.43 number of drinks on peak occasion
Standard Deviation 3.78
|
13.14 number of drinks on peak occasion
Standard Deviation 3.91
|
18.01 number of drinks on peak occasion
Standard Deviation 3.04
|
|
Alcohol Quantity
Week 36
|
13.94 number of drinks on peak occasion
Standard Deviation 3.42
|
14.31 number of drinks on peak occasion
Standard Deviation 3.46
|
12.46 number of drinks on peak occasion
Standard Deviation 3.36
|
16.3 number of drinks on peak occasion
Standard Deviation 2.73
|
PRIMARY outcome
Timeframe: Baseline, week 4, week 8, week 12, week 24, week 36Using the Short Inventory of Problems, we collected data on alcohol-related harm in the past month. The range of possible scores on the single summary score is 0-45, and higher scores indicate a greater experience of alcohol-related harm.
Outcome measures
| Measure |
Assessment-only
n=74 Participants
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=78 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=79 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=77 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
|---|---|---|---|---|
|
Alcohol-related Harm
Baseline
|
23.7 score on a scale
Standard Deviation 12.03
|
23 score on a scale
Standard Deviation 12.05
|
25.69 score on a scale
Standard Deviation 10.25
|
22.7 score on a scale
Standard Deviation 12.05
|
|
Alcohol-related Harm
Week 4
|
15.33 score on a scale
Standard Deviation 11.59
|
17 score on a scale
Standard Deviation 11.43
|
17.98 score on a scale
Standard Deviation 12.51
|
21.39 score on a scale
Standard Deviation 13.67
|
|
Alcohol-related Harm
Week 8
|
13.98 score on a scale
Standard Deviation 12.48
|
15.52 score on a scale
Standard Deviation 12.85
|
17.15 score on a scale
Standard Deviation 11.97
|
18.31 score on a scale
Standard Deviation 14.15
|
|
Alcohol-related Harm
Week 12
|
12.15 score on a scale
Standard Deviation 11.25
|
16.08 score on a scale
Standard Deviation 13.2
|
15.5 score on a scale
Standard Deviation 13.03
|
21 score on a scale
Standard Deviation 14.06
|
|
Alcohol-related Harm
Week 24
|
12.76 score on a scale
Standard Deviation 12.97
|
15.89 score on a scale
Standard Deviation 13.88
|
17.9 score on a scale
Standard Deviation 16.19
|
16.15 score on a scale
Standard Deviation 11.99
|
|
Alcohol-related Harm
Week 36
|
13.35 score on a scale
Standard Deviation 12.5
|
13.19 score on a scale
Standard Deviation 13.4
|
16.87 score on a scale
Standard Deviation 14.54
|
16.36 score on a scale
Standard Deviation 13.62
|
PRIMARY outcome
Timeframe: baseline, week 0, week 4, week 8, week 12, week 24, week 36Population: see https://doi.org/10.1016/s2215-0366(20)30489-2
Addiction Severity Index (ASI - 5th edition) will be used to assess frequency of alcohol use in the past 30 days.
Outcome measures
| Measure |
Assessment-only
n=74 Participants
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=78 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=79 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=77 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
|---|---|---|---|---|
|
Alcohol Frequency
Baseline
|
23.08 Drinking days per month
Standard Deviation 7.55
|
24.63 Drinking days per month
Standard Deviation 8.02
|
23.42 Drinking days per month
Standard Deviation 8.63
|
23.35 Drinking days per month
Standard Deviation 8.66
|
|
Alcohol Frequency
Week 4
|
17.87 Drinking days per month
Standard Deviation 10.85
|
18.81 Drinking days per month
Standard Deviation 11.45
|
17.43 Drinking days per month
Standard Deviation 10.91
|
22.37 Drinking days per month
Standard Deviation 10.46
|
|
Alcohol Frequency
Week 8
|
17.18 Drinking days per month
Standard Deviation 11.83
|
18.67 Drinking days per month
Standard Deviation 11.22
|
18 Drinking days per month
Standard Deviation 11.8
|
20.83 Drinking days per month
Standard Deviation 10.51
|
|
Alcohol Frequency
Week 12
|
15.15 Drinking days per month
Standard Deviation 11.33
|
18.68 Drinking days per month
Standard Deviation 11.45
|
15.32 Drinking days per month
Standard Deviation 11.97
|
17.15 Drinking days per month
Standard Deviation 10.98
|
|
Alcohol Frequency
Week 24
|
16.2 Drinking days per month
Standard Deviation 11.82
|
18.94 Drinking days per month
Standard Deviation 11.68
|
13.04 Drinking days per month
Standard Deviation 11.66
|
17.93 Drinking days per month
Standard Deviation 11.91
|
|
Alcohol Frequency
Week 36
|
15.65 Drinking days per month
Standard Deviation 11.58
|
16.88 Drinking days per month
Standard Deviation 11.12
|
15.02 Drinking days per month
Standard Deviation 11.75
|
14.59 Drinking days per month
Standard Deviation 11.51
|
SECONDARY outcome
Timeframe: baseline, week 4, week 8, week 12, week 24, week 36Motivation to change will be measured using the 10-point motivation ruler, where the stem was "How motivated are you to make changes in your drinking to reduce harm?" and 1= not at all motivated and 10=totally motivated. Thus, higher scores correspond to higher motivation for alcohol harm reduction
Outcome measures
| Measure |
Assessment-only
n=77 Participants
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=79 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=78 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=73 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
|---|---|---|---|---|
|
Motivation to Change Ruler
Baseline
|
6.64 score on a scale
Standard Deviation 2.97
|
7.49 score on a scale
Standard Deviation 2.69
|
7.05 score on a scale
Standard Deviation 2.94
|
6.42 score on a scale
Standard Deviation 3.06
|
|
Motivation to Change Ruler
Week 4
|
6.37 score on a scale
Standard Deviation 3
|
6.98 score on a scale
Standard Deviation 3.11
|
6.43 score on a scale
Standard Deviation 3.06
|
6.61 score on a scale
Standard Deviation 3.02
|
|
Motivation to Change Ruler
Week 8
|
6.39 score on a scale
Standard Deviation 3.1
|
7.48 score on a scale
Standard Deviation 2.62
|
7.13 score on a scale
Standard Deviation 2.79
|
6.33 score on a scale
Standard Deviation 3.05
|
|
Motivation to Change Ruler
Week 12
|
6.08 score on a scale
Standard Deviation 3.33
|
7.07 score on a scale
Standard Deviation 3.14
|
6.32 score on a scale
Standard Deviation 3.32
|
6.64 score on a scale
Standard Deviation 3.05
|
|
Motivation to Change Ruler
Week 24
|
7.3 score on a scale
Standard Deviation 3.07
|
6.92 score on a scale
Standard Deviation 3.03
|
6.87 score on a scale
Standard Deviation 3.1
|
6.59 score on a scale
Standard Deviation 3.3
|
|
Motivation to Change Ruler
Week 36
|
7.34 score on a scale
Standard Deviation 3.16
|
6.85 score on a scale
Standard Deviation 3.19
|
6.71 score on a scale
Standard Deviation 3.3
|
6.81 score on a scale
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: baseline, week 4, week 8, week 12, week 24, week 36Population: see https://doi.org/10.1016/s2215-0366(20)30489-2
Alcohol craving will be measured using the psychometrically valid, 5-item, 6-point Likert-scale Penn Alcohol Craving Scale (PACS). The score ranges from 0-30, with higher scores representing a higher level of craving.
Outcome measures
| Measure |
Assessment-only
n=77 Participants
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=79 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=78 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=74 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
|---|---|---|---|---|
|
Alcohol Craving
Baseline
|
20.74 score on a scale
Standard Deviation 7.68
|
21.99 score on a scale
Standard Deviation 6.18
|
21.46 score on a scale
Standard Deviation 6.9
|
21.70 score on a scale
Standard Deviation 5.79
|
|
Alcohol Craving
Week 8
|
16.6 score on a scale
Standard Deviation 8.83
|
15.8 score on a scale
Standard Deviation 8.92
|
16.15 score on a scale
Standard Deviation 9.04
|
16 score on a scale
Standard Deviation 8.74
|
|
Alcohol Craving
Week 12
|
16.59 score on a scale
Standard Deviation 9.77
|
14.93 score on a scale
Standard Deviation 8.74
|
17.2 score on a scale
Standard Deviation 8.53
|
15.25 score on a scale
Standard Deviation 8.1
|
|
Alcohol Craving
Week 24
|
15.98 score on a scale
Standard Deviation 10.01
|
15.49 score on a scale
Standard Deviation 8.44
|
17.09 score on a scale
Standard Deviation 9.05
|
13.76 score on a scale
Standard Deviation 9.13
|
|
Alcohol Craving
Week 36
|
13.74 score on a scale
Standard Deviation 9.18
|
14.87 score on a scale
Standard Deviation 9.09
|
14.71 score on a scale
Standard Deviation 9.09
|
14.96 score on a scale
Standard Deviation 8.3
|
|
Alcohol Craving
Week 4
|
18.54 score on a scale
Standard Deviation 7.15
|
17.85 score on a scale
Standard Deviation 8.15
|
17.5 score on a scale
Standard Deviation 9.11
|
17.19 score on a scale
Standard Deviation 8.10
|
SECONDARY outcome
Timeframe: 2yr pretest, 12-week treatment period, 24-week follow-up periodAdministrative data on publicly funded service utilization will be obtained from the King County Correctional Facility, King County Medic One/Emergency Medical Services, Harborview Medical Center (HMC), and the Washington State Comprehensive Hospital Abstract Reporting System (CHARS) for the 2-year pre-study period through the 24-week follow-up. We will obtain participant consent and HIPAA authorizations for these data at the information session. We will collect the following data: a) number of Medic One/EMS dispatches and associated costs; b) number of ER visits and associated costs; c) number of inpatient hospital admissions and total costs per admission (CHARS and HMC); d) number of bookings, length of stay and daily cost for the King County Correctional Facility. These data will be used to create overall cost outcomes.
Outcome measures
| Measure |
Assessment-only
n=77 Participants
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=79 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=78 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=74 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
|---|---|---|---|---|
|
Publicly Funded Service Utilization Costs
Pretest
|
722.32 US dollars
Standard Deviation 1054.45
|
829.22 US dollars
Standard Deviation 1447.25
|
583.55 US dollars
Standard Deviation 707.79
|
511.62 US dollars
Standard Deviation 665.10
|
|
Publicly Funded Service Utilization Costs
During treatment
|
1371.51 US dollars
Standard Deviation 2649.40
|
871.57 US dollars
Standard Deviation 1549.52
|
913.43 US dollars
Standard Deviation 1384.25
|
1516.09 US dollars
Standard Deviation 4274.35
|
|
Publicly Funded Service Utilization Costs
Follow-up
|
1576.97 US dollars
Standard Deviation 2871.47
|
1326.28 US dollars
Standard Deviation 2967.28
|
1286.62 US dollars
Standard Deviation 2329.87
|
1277.21 US dollars
Standard Deviation 1876.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, week 4, week 8, week 12, week 24, week 36The Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview,68,69 which was tailored for use with this medication, includes open-ended, categorical and Likert-scale questions assessing symptoms that correspond to potential adverse events associated with XR-NTX. This measure will be embedded in the CRF and will be used to establish tolerability of the study medication. For these descriptive scores, we took the average count of adverse events reported at each time point during the study. This was a total summary score ranging from 0 to 20, where a higher score represents a higher number of adverse events experienced.
Outcome measures
| Measure |
Assessment-only
n=74 Participants
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=78 Participants
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
XR-NTX+HRC
n=79 Participants
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
Placebo+HRC
n=77 Participants
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
|---|---|---|---|---|
|
Adverse Events Due to the Study Medication
|
4.5 mean scale score averaged during study
Standard Deviation 3.37
|
4.88 mean scale score averaged during study
Standard Deviation 3.65
|
5.11 mean scale score averaged during study
Standard Deviation 3.38
|
4.96 mean scale score averaged during study
Standard Deviation 3.84
|
Adverse Events
Assessment-only
Serious events: 16 serious events
Other events: 1 other events
Deaths: 3 deaths
HRC (Harm Reduction Counseling)
Serious events: 18 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo+HRC
Serious events: 19 serious events
Other events: 1 other events
Deaths: 0 deaths
XR-NTX+HRC
Serious events: 18 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Assessment-only
n=77 participants at risk
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=79 participants at risk
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
Placebo+HRC
n=78 participants at risk
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
XR-NTX+HRC
n=74 participants at risk
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
|---|---|---|---|---|
|
General disorders
Hospitalization
|
16.9%
13/77 • Number of events 13 • weeks 0, 4, 8, 12, 24, 36
|
21.5%
17/79 • Number of events 17 • weeks 0, 4, 8, 12, 24, 36
|
24.4%
19/78 • Number of events 19 • weeks 0, 4, 8, 12, 24, 36
|
23.0%
17/74 • Number of events 17 • weeks 0, 4, 8, 12, 24, 36
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/79 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/78 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
1.4%
1/74 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
|
General disorders
death
|
3.9%
3/77 • Number of events 3 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/79 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/78 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
Other adverse events
| Measure |
Assessment-only
n=77 participants at risk
Assessment-only control condition
|
HRC (Harm Reduction Counseling)
n=79 participants at risk
Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.
HRC
|
Placebo+HRC
n=78 participants at risk
3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period
Placebo+HRC
|
XR-NTX+HRC
n=74 participants at risk
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.
XR-NTX+HRC
|
|---|---|---|---|---|
|
Product Issues
Vomiting
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/79 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/78 • weeks 0, 4, 8, 12, 24, 36
|
1.4%
1/74 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
Increased appetite
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/79 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/78 • weeks 0, 4, 8, 12, 24, 36
|
1.4%
1/74 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
Abdominal pain
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/79 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/78 • weeks 0, 4, 8, 12, 24, 36
|
1.4%
1/74 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
Somnolence
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/79 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/78 • weeks 0, 4, 8, 12, 24, 36
|
1.4%
1/74 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
Decresed appetite
|
1.3%
1/77 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/79 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/78 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
headache
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/79 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/78 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
injection site irritation
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/79 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/78 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
dizziness
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/79 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/78 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
fatigue
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/79 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/78 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
insomnia
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/79 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/78 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
|
Product Issues
depressive symptoms
|
0.00%
0/77 • weeks 0, 4, 8, 12, 24, 36
|
1.3%
1/79 • Number of events 1 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/78 • weeks 0, 4, 8, 12, 24, 36
|
0.00%
0/74 • weeks 0, 4, 8, 12, 24, 36
|
Additional Information
Dr. Susan Collins
University of Washington / Washington State University
Phone: 12068327885
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place