Using 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.
Motivation 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
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.
Baseline
Group
Value
95% CI
Assessment-only
20.74
± 7.68
HRC (Harm Reduction Counseling)
21.99
± 6.18
Placebo+HRC
21.46
± 6.9
XR-NTX+HRC
21.70
± 5.79
Week 4
Group
Value
95% CI
Assessment-only
18.54
± 7.15
HRC (Harm Reduction Counseling)
17.85
± 8.15
Placebo+HRC
17.5
± 9.11
XR-NTX+HRC
17.19
± 8.10
Week 8
Group
Value
95% CI
Assessment-only
16.6
± 8.83
HRC (Harm Reduction Counseling)
15.8
± 8.92
Placebo+HRC
16.15
± 9.04
XR-NTX+HRC
16
± 8.74
Week 12
Group
Value
95% CI
Assessment-only
16.59
± 9.77
HRC (Harm Reduction Counseling)
14.93
± 8.74
Placebo+HRC
17.2
± 8.53
XR-NTX+HRC
15.25
± 8.1
Week 24
Group
Value
95% CI
Assessment-only
15.98
± 10.01
HRC (Harm Reduction Counseling)
15.49
± 8.44
Placebo+HRC
17.09
± 9.05
XR-NTX+HRC
13.76
± 9.13
Week 36
Group
Value
95% CI
Assessment-only
13.74
± 9.18
HRC (Harm Reduction Counseling)
14.87
± 9.09
Placebo+HRC
14.71
± 9.09
XR-NTX+HRC
14.96
± 8.3
Publicly Funded Service Utilization CostsSecondary· 2yr pretest, 12-week treatment period, 24-week follow-up period
Administrative 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) numbe
Pretest
Group
Value
95% CI
Assessment-only
722.32
± 1054.45
HRC (Harm Reduction Counseling)
829.22
± 1447.25
XR-NTX+HRC
583.55
± 707.79
Placebo+HRC
511.62
± 665.10
During treatment
Group
Value
95% CI
Assessment-only
1371.51
± 2649.40
HRC (Harm Reduction Counseling)
871.57
± 1549.52
XR-NTX+HRC
913.43
± 1384.25
Placebo+HRC
1516.09
± 4274.35
Follow-up
Group
Value
95% CI
Assessment-only
1576.97
± 2871.47
HRC (Harm Reduction Counseling)
1326.28
± 2967.28
XR-NTX+HRC
1286.62
± 2329.87
Placebo+HRC
1277.21
± 1876.49
Adverse Events Due to the Study MedicationSecondary· baseline, week 4, week 8, week 12, week 24, week 36
The 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
Group
Value
95% CI
XR-NTX+HRC
4.5
± 3.37
Placebo+HRC
4.88
± 3.65
Harm-reduction Counseling (HRC)
5.11
± 3.38
Assessment-only
4.96
± 3.84
Adverse events — posted to ClinicalTrials.gov
Time frame: weeks 0, 4, 8, 12, 24, 36.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this study is to test the efficacy of extended-release naltrexone and harm reduction counseling in reducing alcohol-related harm among homeless people with alcohol dependence.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 10 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01932801.