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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA022309-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Alkermes, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| XR-NTX+HRC | Experimental | 3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months. |
|
| Placebo+HRC | Placebo Comparator | 3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XR-NTX | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, week 4, week 8, week 12, week 24, week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Due to the Study Medication | 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 number of adverse events experienced. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Collins, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington - Harborview Medical Center | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24846619 | Background | 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. | |
| 33713622 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo+HRC | 3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period Placebo+HRC |
| FG002 | 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 |
| FG003 | Assessment-only | Assessment-only control condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Assessment-only | Assessment-only control condition |
| BG001 | HRC - Harm Reduction Counseling | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Quantity | Using the Alcohol Quantity and Use Assessment, we will collect data on peak alcohol quantity. | Posted | Mean | Standard Deviation | number of drinks on peak occasion | Baseline, week 4, week 8, week 12, week 24, week 36 |
|
weeks 0, 4, 8, 12, 24, 36
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assessment-only | Assessment-only control condition | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | One SAE was ascribed to the study procedures: difficulties ambulating due to an injection site hematoma that led to an emergency department visit, which precipitated alcohol withdrawal and subsequent hospital admission. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Collins | University of Washington / Washington State University | 12068327885 | susan.collins@wsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2015 | Nov 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 16, 2017 | Nov 26, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Masking of the double-blind portion of the study was quadruple until after all data had been collected, when they were unblinded.
|
| HRC | Behavioral |
|
| 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. | 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. | 2yr pretest, 12-week treatment period, 24-week follow-up period |
| baseline, week 4, week 8, week 12, week 24, week 36 |
| 34264737 | 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. |
| 35511527 | 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. |
| BG002 | 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 |
| BG003 | Placebo+HRC | 3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period Placebo+HRC |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months. XR-NTX+HRC |
| OG003 | Placebo+HRC | 3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period Placebo+HRC |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, week 8, week 12, week 24, week 36 |
|
|
|
|
| Primary | Alcohol Frequency | Addiction Severity Index (ASI - 5th edition) will be used to assess frequency of alcohol use in the past 30 days. | Posted | Mean | Standard Deviation | Drinking days per month | baseline, week 0, week 4, week 8, week 12, week 24, week 36 |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | baseline, week 4, week 8, week 12, week 24, week 36 |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, week 4, week 8, week 12, week 24, week 36 |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | US dollars | 2yr pretest, 12-week treatment period, 24-week follow-up period |
|
|
|
|
| Other Pre-specified | Adverse Events Due to the Study Medication | 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 number of adverse events experienced. | Posted | Mean | Standard Deviation | mean scale score averaged during study | baseline, week 4, week 8, week 12, week 24, week 36 |
|
|
|
|
| 77 |
| 16 |
| 77 |
| 1 |
| 77 |
| EG001 | HRC (Harm Reduction Counseling) | 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 | 0 | 79 | 18 | 79 | 1 | 79 |
| EG002 | Placebo+HRC | 3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period Placebo+HRC | 0 | 78 | 19 | 78 | 1 | 78 |
| EG003 | 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 | 0 | 74 | 18 | 74 | 3 | 74 |
|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
|
| death | General disorders | Systematic Assessment | no association with procedures |
|
|
| Increased appetite | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| Abdominal pain | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| Somnolence | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| Decresed appetite | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| headache | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| injection site irritation | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| dizziness | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| fatigue | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| insomnia | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
| depressive symptoms | Product Issues | Systematic Assessment | Event reported during study timeline that did not occur at baseline |
|
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| D001519 | Behavior |
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| Week 24 |
|
| Week 36 |
|
| Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2 | z | .002 | Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables) | Slope | -2.22 | 2-Sided | 95 | -3.39 | -1.06 | Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables) | Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2 | z | .208 | Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables) | Slope | -.82 | 2-Sided | 95 | -1.89 | .25 | Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables) | Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2 | z | .025 | Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables) | Slope | -1.58 | 2-Sided | 95 | -2.73 | -.42 | Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables) | Superiority |
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| Week 24 |
|
| Week 36 |
|
| Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2 | z | .047 | Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables) | Slope | -4.42 | 2-Sided | 95 | -8.09 | -.76 | Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables) | Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2 | z | .009 | Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables) | Slope | -5.95 | 2-Sided | 95 | -9.72 | -2.19 | Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables) | Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2 | z | .072 | Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables) | Slope | -4.12 | 2-Sided | 95 | -7.88 | -.36 | Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables) | Superiority |
| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Other |
Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .83 | Slope | -.04 | Standard Error of the Mean | .18 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .89 | Slope | -.02 | Standard Error of the Mean | .17 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol frequency. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .65 | Slope | -.01 | Standard Error of the Mean | .02 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol quantity. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .87 | Slope | -.003 | Standard Error of the Mean | .02 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the placebo vs control group effects on alcohol quantity. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .91 | Slope | -.002 | Standard Error of the Mean | .02 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol quantity. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .54 | Slope | .24 | Standard Error of the Mean | .38 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol related harm. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .84 | Slope | .06 | Standard Error of the Mean | .32 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the placebo vs control effects on alcohol-related harm. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .84 | Slope | .06 | Standard Error of the Mean | .29 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol related harm | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| Week 4 |
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| Week 8 |
|
| Week 12 |
|
| Week 24 |
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| Week 36 |
|
Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .46 | Slope | -.03 | Standard Error of the Mean | .04 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails 2 treatment arms: XR-NTX vs placebo effects on craving and alcohol quantity. | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a*b is considered the mediated effect) for during-treatment effects (baseline to week 12). | z | .45 | Slope | -.57 | Standard Error of the Mean | .75 | 2-Sided | We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on craving and alcohol-related harm | Other | Mediation tested using the product of coefficients (a*b) approach (MacKinnon et al, 2002). |
| During treatment |
|
| Follow-up |
|
| Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. | Chi-squared | .75 | Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables) | Slope | -.04 | 2-Sided | 95 | -.24 | .16 | Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. | Chi-squared | Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables) | .20 | Slope | -.15 | 2-Sided | 95 | -.34 | .04 | Superiority |
| These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called "analysis 1". These are not separate analyses, but select parameters within a single SEM model. | Chi-squared | Linear effects of HaRT-A compared to services-as usual control during treatment period (one of three dummy-coded variables) | .39 | Slope | .10 | 2-Sided | 95 | -.09 | .29 | Superiority |