<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04441593</url>
  </required_header>
  <id_info>
    <org_study_id>4546 [Study 3]</org_study_id>
    <secondary_id>UH3AA026192</secondary_id>
    <nct_id>NCT04441593</nct_id>
  </id_info>
  <brief_title>Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial</brief_title>
  <official_title>Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University Charles River Campus</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study seeks to provide effect size estimates and test feasibility of a novel,&#xD;
      integrated behavioral approach to reduce heavy drinking and chronic pain among patients in&#xD;
      HIV-care delivered via internet-based videoconferencing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is a between-groups design to compare a novel integrated behavioral video&#xD;
      telehealth intervention for heavy drinking PLWH with chronic pain to a control condition.&#xD;
      Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be&#xD;
      recruited for the study. Following baseline assessment, participants will be randomly&#xD;
      assigned to either intervention or control conditions. Participants will complete assessment&#xD;
      measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline.&#xD;
      Secondary alcohol outcomes will include alcohol-related consequences&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 23, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Compare Intervention to Control Condition in a Between Subjects Design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Three and six month assessments will be conducted by RA who is masked to intervention condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes</measure>
    <time_frame>Past 30 days</time_frame>
    <description>Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol Time Line Follow-Back (30) - Average Drinks per Week</measure>
    <time_frame>Past 30 days</time_frame>
    <description>Average number of standard alcohol-containing drinks in the past 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Pain Inventory - Pain Severity</measure>
    <time_frame>Past 7 days</time_frame>
    <description>BPI is an 11-point scale anchored with &quot;0&quot; best and &quot;10&quot; is worst Scale range 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Pain Inventory - Pain Interference</measure>
    <time_frame>Past 7-Days</time_frame>
    <description>BPI is an 11-point scale anchored with &quot;0&quot; best and &quot;10&quot; is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Inventory of Alcohol Problems-Revised</measure>
    <time_frame>3 months</time_frame>
    <description>17-item measure with 4-point Likert scale items ranging from &quot;0&quot; never to &quot;3&quot; daily/almost daily. Scale range 0-51</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal Systems Assessment Battery-Alcohol</measure>
    <time_frame>Past 30 days</time_frame>
    <description>Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal Systems Assessment Battery-Pain</measure>
    <time_frame>Past 30 days</time_frame>
    <description>Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Alcohol Drinking and Chronic Pain Intervention</condition>
  <condition>Control Condition</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Videoconferencing Intervention for Heavy Drinking and Chronic Pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)</intervention_name>
    <description>Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Psychoeducation and Information about Treatment Resources</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  engaged in HIV care, heavy drinking defined as more than 7/14 drinks per week for&#xD;
             women/men or by a single episode of 4/5 (women/men), chronic (at least 3 months&#xD;
             duration) moderate or greater (4 or more on the severity scale of the BPI, and&#xD;
             non-cancer related pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychoactive medication for pain or alcohol use for fewer than 2 months&#xD;
&#xD;
          -  history of bipolar disorder or schizophrenia&#xD;
&#xD;
          -  current expressed suicidal intent&#xD;
&#xD;
          -  prior history of alcohol withdrawal related seizures or delirium tremens&#xD;
&#xD;
          -  current behavioral treatment for pain or alcohol use&#xD;
&#xD;
          -  any scheduled surgery within the next 6 months or acute life threatening illness that&#xD;
             requires treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tibor Palfai, PhD</last_name>
    <phone>617-353-9345</phone>
    <email>palfai@bu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maya Kratzer, BA</last_name>
    <phone>857-225-8843</phone>
    <email>mkratzer@bu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston University Department of Psychological and Brain Sciences</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tibor P. Palfai, PhD</last_name>
      <phone>617-353-9345</phone>
      <email>palfai@bu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>General Clinical Research Unit, Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ridiane Denis, MD</last_name>
      <phone>617-358-7558</phone>
      <email>ridianed@bu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>For proposals that contain analyses that are not already planned or in progress, the investigators will make data available for collaboration with a study investigator, provided IRB and other appropriate regulatory approvals are obtained (including but not limited to Federal and Boston University IRB review and approval). Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Twelve months following request, de-identified data will be available to investigators upon request. This access will be provided for 7 years following publication of main trial</ipd_time_frame>
    <ipd_access_criteria>Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit. Limited public-use data sets may also be prepared and made available in a web-data archive to be developed and maintained by the data coordinating center (BEDAC).</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441593
org study id: 4546 [Study 3]
secondary id: UH3AA026192
nct id: NCT04441593
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This pilot study seeks to provide effect size estimates and test feasibility of a novel,
      integrated behavioral approach to reduce heavy drinking and chronic pain among patients in
      HIV-care delivered via internet-based videoconferencing.
This pilot study is a between-groups design to compare a novel integrated behavioral video
      telehealth intervention for heavy drinking PLWH with chronic pain to a control condition.
      Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be
      recruited for the study. Following baseline assessment, participants will be randomly
      assigned to either intervention or control conditions. Participants will complete assessment
      measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline.
      Secondary alcohol outcomes will include alcohol-related consequences
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Compare Intervention to Control Condition in a Between Subjects Design
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Three and six month assessments will be conducted by RA who is masked to intervention condition
measure: Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes
time frame: Past 30 days
description: Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)
measure: Alcohol Time Line Follow-Back (30) - Average Drinks per Week
time frame: Past 30 days
description: Average number of standard alcohol-containing drinks in the past 30 days
measure: Brief Pain Inventory - Pain Severity
time frame: Past 7 days
description: BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10
measure: Brief Pain Inventory - Pain Interference
time frame: Past 7-Days
description: BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale
measure: Short Inventory of Alcohol Problems-Revised
time frame: 3 months
description: 17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51
measure: Goal Systems Assessment Battery-Alcohol
time frame: Past 30 days
description: Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes
measure: Goal Systems Assessment Battery-Pain
time frame: Past 30 days
description: Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes
arm group label: Intervention
arm group type: Experimental
description: Videoconferencing Intervention for Heavy Drinking and Chronic Pain
arm group label: Control
arm group type: Active Comparator
description: Treatment as Usual
intervention type: Behavioral
intervention name: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)
description: Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity
arm group label: Intervention
other name: Intervention
intervention type: Behavioral
intervention name: Treatment as Usual
description: Psychoeducation and Information about Treatment Resources
arm group label: Control
other name: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tibor Palfai, PhD
phone: 617-353-9345
email: palfai@bu.edu
last name: Maya Kratzer, BA
phone: 857-225-8843
email: mkratzer@bu.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Alcohol Drinking
sharing ipd: Yes
ipd description: For proposals that contain analyses that are not already planned or in progress, the investigators will make data available for collaboration with a study investigator, provided IRB and other appropriate regulatory approvals are obtained (including but not limited to Federal and Boston University IRB review and approval). Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Twelve months following request, de-identified data will be available to investigators upon request. This access will be provided for 7 years following publication of main trial
ipd access criteria: Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit. Limited public-use data sets may also be prepared and made available in a web-data archive to be developed and maintained by the data coordinating center (BEDAC).