Harm Reduction With Pharmacotherapy (HaRP)

NCT01932801 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 451341R01AA022309-01
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

harm reduction, naltrexone, alcohol use disorder, homelessness

Outcome Measures

Primary Outcomes (3)

• Alcohol Quantity

  Using the Alcohol Quantity and Use Assessment, we will collect data on peak alcohol quantity.

  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.

  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.

  baseline, week 0, week 4, week 8, week 12, week 24, week 36

Secondary Outcomes (3)

• Motivation to Change Ruler

  baseline, week 4, week 8, week 12, week 24, week 36

• Alcohol Craving

  baseline, week 4, week 8, week 12, week 24, week 36

• Publicly Funded Service Utilization Costs

  2yr pretest, 12-week treatment period, 24-week follow-up period

Other Outcomes (1)

• Adverse Events Due to the Study Medication

  baseline, week 4, week 8, week 12, week 24, week 36

Study Arms (4)

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.

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.

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

Other: Placebo; Behavioral: HRC

Interventions

XR-NTX DRUG

XR-NTX+HRC

Placebo OTHER

Placebo+HRC

HRC BEHAVIORAL

HRC; Placebo+HRC; XR-NTX+HRC

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Alkermes, Inc.: collaborator

Study Sites (1)

University of Washington - Harborview Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (4)

• 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.

  PMID: 24846619 BACKGROUND

• Collins 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.

  PMID: 33713622 BACKGROUND

• Fentress 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.

  PMID: 34264737 BACKGROUND

• Goldstein 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.

  PMID: 35511527 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Harm Reduction

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

1\) The treatments' relative brevity did not mirror longer-term clinical contacts this population often receives. 2) We cannot preclude experimenter bias or expectancy effects for unblinded arms. 3) Data missingness can reduce power and bias estimates, but missingness modeling lent confidence that findings are robust. 4) Generalizability may be limited by geographic location, sociodemographics, and substance-use patterns specific to the homeless population in the study area.

Results Point of Contact

• Title: Dr. Susan Collins
• Organization: University of Washington / Washington State University

susan.collins@wsu.edu

12068327885

Study Officials

• Susan E Collins, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking of the double-blind portion of the study was quadruple until after all data had been collected, when they were unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 30, 2013
• Study Start: August 1, 2013
• Primary Completion: October 11, 2018
• Study Completion: June 30, 2019
• Last Updated: May 10, 2023
• Results First Posted: May 10, 2023

Record last verified: 2023-05

Locations

US (1)