Alcohol Use DisorderPhase 2HaRPNCT01932801
Harm Reduction With Pharmacotherapy (HaRP)
A Phase 2 study testing XR-NTX and HRC in people with Alcohol Use Disorder, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- XR-NTX and HRC
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 30 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being a registered client at one of the named partnering sites
- being at least 21 years of age (for legal reasons)
- agreeing to use an adequate form of birth control (if female and in childbearing years) fulfilling criteria for current alcohol dependence according to DSM-IV-TR criteria as determined by the SCID-I/P
Who cannot join
- refusal or inability to consent to participation in research
- constituting a risk to safety and security of other clients or staff
- known sensitivity or allergy to naltrexone/XR-NTX
- current treatment with naltrexone/XR-NTX
- being pregnant or nursing
- suicide attempts within the past year
Show all 10Show fewer
- renal insufficiency/serum creatinine level > 1.5
- current opioid dependence according to the DSM-IV-TR criteria
- liver transaminases (AST, ALT) > 5 times the upper limit of normal (ULN)
- clinical diagnosis of decompensated liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington - Harborview Medical Center
Seattle, Washington, 98195
About this study
Official title: Harm Reduction With Pharmacotherapy for Homeless Adults With Alcohol Dependence
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.
Read the detailed description
Homelessness and alcohol dependence are commonly co-occurring and serious public health issues. Unfortunately, abstinence-based alcohol treatment approaches are minimally effective in engaging and successfully treating homeless individuals with alcohol dependence. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. Innovative, low-barrier approaches (e.g., Housing First and alcohol management programs) have been applied with this population and are efficacious in reducing alcohol use and related problems as well as utilization of publicly funded services and associated costs. Such approaches have been referred to as harm-reduction interventions because they focus on reducing alcohol-related harm for affected individuals and their communities without requiring a commitment to abstinence-based goals. Although psychosocial, harm-reduction approaches are beginning to proliferate for this population, there are few pharmacological counterparts to support and enhance these efforts. One medication that could address this treatment gap is extended-release naltrexone (XR-NTX; marketed as Vivitrol®). XR-NTX is a 30-day, extended release formulation of the opioid receptor antagonist, naltrexone, and is administered monthly via gluteal intramuscular injection. The proposed Phase II study features a four-arm RCT (N=300) designed to test the efficacy of XR-NTX as a pharmacological adjunct to existing psychosocial harm-reduction services provided by community agencies to homeless people with alcohol dependence. The proposed study will include a 24-week follow-up and will test the relative efficacy of 3 active treatment combinations-1) XR-NTX+harm reduction counseling, 2) placebo+harm reduction counseling and 3) harm reduction counseling only (HRC)-compared to the services as usual (TAU) that all participants receive from community agencies. This proposed design will allow us to dismantle active treatment components and thereby detect potential "placebo effects" of both the administration of an injection and attention from a medical professional. In this study, there are three primary specific aims. First, we will test the relative efficacy of XR-NTX, placebo and HRC compared to TAU in decreasing alcohol quantity, frequency and alcohol-related problems. Second, we will test hypothesized mediators of the intervention effects. Specifically, we hypothesize that the active treatments will precipitate increases in motivation to change and decreases in craving, which, in turn, will mediate the active treatment effects on alcohol outcomes. Finally, we will test treatment effects on publicly funded service costs (i.e., emergency medical services, ER visits, hospital admissions, and county jail). It is hypothesized that XR-NTX, placebo and HRC groups will show greater decreases in publicly funded service costs than the TAU group.
- Conditions
- Alcohol Use Disorder
- Being tested
- XR-NTX, Placebo, HRC
- Keywords
- harm reduction, naltrexone, alcohol use disorder, homelessness
- Medical subject headings
- Alcoholism, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XR-NTXDrug
PlaceboOther
HRCBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Assessment-only | No intervention | Assessment-only control condition |
| HRC | Active comparator | 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. Receives: Behavioral: HRC |
| XR-NTX+HRC | Experimental | 3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months. Receives: Drug: XR-NTX; Behavioral: HRC |
| Placebo+HRC | Placebo comparator | 3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period Receives: Other: Placebo; Behavioral: HRC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Quantity
Using the Alcohol Quantity and Use Assessment, we will collect data on peak alcohol quantity.
Measured: Baseline, week 4, week 8, week 12, week 24, week 36
Alcohol-related Harm
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.
Measured: Baseline, week 4, week 8, week 12, week 24, week 36
Alcohol Frequency
Addiction Severity Index (ASI - 5th edition) will be used to assess frequency of alcohol use in the past 30 days.
Measured: baseline, week 0, week 4, week 8, week 12, week 24, week 36
Secondary outcomes (3)
Motivation to Change Ruler
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
Measured: baseline, week 4, week 8, week 12, week 24, week 36
Alcohol Craving
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.
Measured: baseline, week 4, week 8, week 12, week 24, week 36
Publicly Funded Service Utilization Costs
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) 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.
Measured: 2yr pretest, 12-week treatment period, 24-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start1 Aug 2013
- Primary completion11 Oct 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Alkermes, Inc.
- Responsible party
- Principal investigator, Susan Collins, University of Washington
- Investigators
- Susan E Collins, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932801
- Sponsor's protocol ID
- 45134
- Other IDs
- 1R01AA022309-01
- Acronym
- HaRP
- Status last verified
- May 2023
- First submitted
- 22 Aug 2013
- Last updated
- 10 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Collins SE, Saxon AJ, Duncan MH, Smart BF, Merrill JO, Malone DK, Jackson TR, Clifasefi SL, Joesch J, Ries RK. Harm reduction with pharmacotherapy for homeless people with alcohol dependence: protocol for a randomized controlled trial. Contemp Clin Trials. 2014 Jul;38(2):221-34. doi: 10.1016/j.cct.2014.05.008. Epub 2014 May 17.
PubMed 24846619Collins SE, Duncan MH, Saxon AJ, Taylor EM, Mayberry N, Merrill JO, Hoffmann GE, Clifasefi SL, Ries RK. Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial. Lancet Psychiatry. 2021 Apr;8(4):287-300. doi: 10.1016/S2215-0366(20)30489-2. Epub 2021 Mar 10.
PubMed 33713622Fentress TSP, Wald S, Brah A, Leemon G, Reyes R, Alkhamees F, Kramer M, Taylor EM, Wildhood M, Frohe T, Duncan MH, Clifasefi SL, Collins SE. Dual study describing patient-driven harm reduction goal-setting among people experiencing homelessness and alcohol use disorder. Exp Clin Psychopharmacol. 2021 Jun;29(3):261-271. doi: 10.1037/pha0000470.
PubMed 34264737Goldstein SC, Spillane NS, Tate MC, Nelson LA, Collins SE. Measurement invariance and other psychometric properties of the Short Inventory of Problems (SIP-2R) across racial groups in adults experiencing homelessness and alcohol use disorder. Psychol Addict Behav. 2023 Mar;37(2):199-208. doi: 10.1037/adb0000833. Epub 2022 May 5.
PubMed 35511527
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harm Reduction With Pharmacotherapy for Homeless Adults With Alcohol Dependence
- ClinicalTrials.gov ID
- NCT01932801
- Acronym / sponsor ID
- HaRP / 45134
- Conditions
- Alcohol Use Disorder
- Keywords
- harm reduction, naltrexone, alcohol use disorder, homelessness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Alkermes, Inc.
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Homelessness and alcohol dependence are commonly co-occurring and serious public health issues. Unfortunately, abstinence-based alcohol treatment approaches are minimally effective in engaging and successfully treating homeless individuals with alcohol dependence. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. Innovative, low-barrier approaches (e.g., Housing First and alcohol management programs) have been applied with this population and are efficacious in reducing alcohol use and related problems as well as utilization of publicly funded services and associated costs. Such approaches have been referred to as harm-reduction interventions because they focus on reducing alcohol-related harm for affected individuals and their communities without requiring a commitment to abstinence-based goals. Although psychosocial, harm-reduction approaches are beginning to proliferate for this population, there are few pharmacological counterparts to support and enhance these efforts. One medication that could address this treatment gap is extended-release naltrexone (XR-NTX; marketed as Vivitrol®). XR-NTX is a 30-day, extended release formulation of the opioid receptor antagonist, naltrexone, and is administered monthly via gluteal intramuscular injection. The proposed Phase II study features a four-arm RCT (N=300) designed to test the efficacy of XR-NTX as a pharmacological adjunct to existing psychosocial harm-reduction services provided by community agencies to homeless people with alcohol dependence. The proposed study will include a 24-week follow-up and will test the relative efficacy of 3 active treatment combinations-1) XR-NTX+harm reduction counseling, 2) placebo+harm reduction counseling and 3) harm reduction counseling only (HRC)-compared to the services as usual (TAU) that all participants receive from community agencies. This proposed design will allow us to dismantle active treatment components and thereby detect potential "placebo effects" of both the administration of an injection and attention from a medical professional. In this study, there are three primary specific aims. First, we will test the relative efficacy of XR-NTX, placebo and HRC compared to TAU in decreasing alcohol quantity, frequency and alcohol-related problems. Second, we will test hypothesized mediators of the intervention effects. Specifically, we hypothesize that the active treatments will precipitate increases in motivation to change and decreases in craving, which, in turn, will mediate the active treatment effects on alcohol outcomes. Finally, we will test treatment effects on publicly funded service costs (i.e., emergency medical services, ER visits, hospital admissions, and county jail). It is hypothesized that XR-NTX, placebo and HRC groups will show greater decreases in publicly funded service costs than the TAU group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Assessment-only | No intervention | –Assessment-only control condition |
| HRC | Active comparator | Behavioral: HRCHarm 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. |
| XR-NTX+HRC | Experimental | Drug: XR-NTX, Behavioral: HRC3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months. |
| Placebo+HRC | Placebo comparator | Other: Placebo, Behavioral: HRC3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being a registered client at one of the named partnering sites
- being at least 21 years of age (for legal reasons)
- agreeing to use an adequate form of birth control (if female and in childbearing years) fulfilling criteria for current alcohol dependence according to DSM-IV-TR criteria as determined by the SCID-I/P
Key exclusion criteria (10 listed)
- refusal or inability to consent to participation in research
- constituting a risk to safety and security of other clients or staff
- known sensitivity or allergy to naltrexone/XR-NTX
- current treatment with naltrexone/XR-NTX
- being pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XR-NTX | Drug | XR-NTX+HRC |
| Placebo | Other | Placebo+HRC |
| HRC | Behavioural | HRC, Placebo+HRC, XR-NTX+HRC |
Primary outcome
Alcohol Quantity
Time frame: Baseline, week 4, week 8, week 12, week 24, week 36
Using the Alcohol Quantity and Use Assessment, we will collect data on peak alcohol quantity.
Alcohol-related Harm
Time frame: Baseline, week 4, week 8, week 12, week 24, week 36
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.
Alcohol Frequency
Time frame: baseline, week 0, week 4, week 8, week 12, week 24, week 36
Addiction Severity Index (ASI - 5th edition) will be used to assess frequency of alcohol use in the past 30 days.
3 secondary outcomes
Motivation to Change Ruler
Time frame: baseline, week 4, week 8, week 12, week 24, week 36
Alcohol Craving
Time frame: baseline, week 4, week 8, week 12, week 24, week 36
Publicly Funded Service Utilization Costs
Time frame: 2yr pretest, 12-week treatment period, 24-week follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24846619Collins SE, Saxon AJ, Duncan MH, Smart BF, Merrill JO, Malone DK, Jackson TR, Clifasefi SL, Joesch J, Ries RK. Harm reduction with pharmacotherapy for homeless people with alcohol dependence: protocol for a randomized controlled trial. Contemp Clin Trials. 2014 Jul;38(2):221-34. doi: 10.1016/j.cct.2014.05.008. Epub 2014 May 17.
- Background: PubMed 33713622Collins SE, Duncan MH, Saxon AJ, Taylor EM, Mayberry N, Merrill JO, Hoffmann GE, Clifasefi SL, Ries RK. Combining behavioral harm-reduction treatment and extended-release naltrexone for people experiencing homelessness and alcohol use disorder in the USA: a randomised clinical trial. Lancet Psychiatry. 2021 Apr;8(4):287-300. doi: 10.1016/S2215-0366(20)30489-2. Epub 2021 Mar 10.
- Background: PubMed 34264737Fentress TSP, Wald S, Brah A, Leemon G, Reyes R, Alkhamees F, Kramer M, Taylor EM, Wildhood M, Frohe T, Duncan MH, Clifasefi SL, Collins SE. Dual study describing patient-driven harm reduction goal-setting among people experiencing homelessness and alcohol use disorder. Exp Clin Psychopharmacol. 2021 Jun;29(3):261-271. doi: 10.1037/pha0000470.
- Background: PubMed 35511527Goldstein SC, Spillane NS, Tate MC, Nelson LA, Collins SE. Measurement invariance and other psychometric properties of the Short Inventory of Problems (SIP-2R) across racial groups in adults experiencing homelessness and alcohol use disorder. Psychol Addict Behav. 2023 Mar;37(2):199-208. doi: 10.1037/adb0000833. Epub 2022 May 5.
Related trials for Alcohol Use Disorder
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
Alcohol Use Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Collins, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XR-NTX and HRC in people with Alcohol Use Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Quantity (time frame: Baseline, week 4, week 8, week 12, week 24, week 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932801, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.