NCT05036499

Brief Summary

There is a pressing public health need to develop novel interventions that aim to reduce alcohol consumption and concurrent alcohol among hazardous drinkers with comorbid chronic pain. The proposed study will draw upon NIH treatment development guidelines (Stage 1) to translate and innovate past work to address a major public health priority. Specifically, we propose to develop (Phase IA) and pilot test (Phase IB) a brief, integrated, single-session, computer-based personalized feedback intervention (PFI) designed to 1) enhance knowledge regarding adverse pain-related anxiety-alcohol interrelations; and (2) increase motivation and intention to reduce hazardous drinking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

August 6, 2021

Last Update Submit

December 11, 2023

Conditions

Alcohol ProblemChronic PainAlcohol Abuse

Outcome Measures

Primary Outcomes (4)

  • Hazardous Drinking

    Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking

    2 weeks post intervention

  • Hazardous Drinking

    Alcohol Use Disorders Identification Test - Scores below 8 (males) and 7 (females) indicate non-hazardous drinking

    1 month post intervention

  • Drinking Quantitiy/Frequency

    Timeline Follow Back will be used to assess past 2 week drinking quantity and frequency, and an average alcohol consumption variable will be created

    2 weeks post intervention

  • Drinking Quantitiy/Frequency

    Timeline Follow Back will be used to assess past 2 week drinking quantity and frequency, and an average alcohol consumption variable will be created

    1 month post intervention

Secondary Outcomes (6)

  • Pain-related Anxiety

    Immediately Post intervention

  • Pain-related Anxiety

    2 weeks post intervention

  • Pain-related Anxiety

    1 month post intervention

  • Motivation to Reduce Drinking

    Immediately Post intervention

  • Motivation to Reduce Drinking

    2 weeks post intervention

  • +1 more secondary outcomes

Study Arms (2)

Personalized Feedback Intervention (PFI)

EXPERIMENTAL

Personalized Feedback Intervention targeting pain-related anxiety for hazardous drinkers with chronic pain

Behavioral: Personalized Feedback Intervention

Assessment Only

NO INTERVENTION

Assessment only, no active treatment elements

Interventions

Personalized Feedback InterventionBEHAVIORAL

Providing corrective normative feedback on alcohol use, psychoeducation on the interplay between pain and alcohol use, and providing exercises to target pain-related anxiety

Personalized Feedback Intervention (PFI)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 21 years of age
  • Current hazardous drinking pattern (AUDIT scores ≥ 8 for males and ≥ 7 for females)
  • Current chronic pain (1) on most days of the week (i.e., 4 or more days per week), (2) at an average weekly severity of 3 or greater on a 0-10 numerical rating scale, and (3) for at least three months in duration
  • Fluent in English

You may not qualify if:

  • Concurrent alcohol or other substance use treatment
  • Not being fluent in English
  • Current acute psychiatric distress or thought disorder
  • Current imminent risk of suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersChronic PainAlcoholism

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael J Zvolensky, Ph.D.

    University of Houston

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2021

First Posted

September 5, 2021

Study Start

September 27, 2021

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)