NCT05124119

Brief Summary

The overall goal of this research project will be to obtain feedback from consumers to help develop a manual called I-DREM (Innovative Development of Research Engagement Manual). The researchers hope to learn information from the consented participants to help map out solutions to improve recruitment of African American/Black individuals into Substance Abuse Disorder (SUD) clinical trials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

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

November 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 5, 2021

Last Update Submit

December 18, 2025

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

  • Change in knowledge Acquisition Scores

    The "Research Knowledge Questionnaire" measures participants' knowledge acquisition. Possible score ranges from 0 - 100 i.e., 0-24 referring to low knowledge, 25-49 referring to below average, 51-74 referring to good scores, and 75-100 higher scores indicating excellent and higher knowledge acquisition (research knowledge).

    Baseline Day 1-15 (pre-focus group), Post focus group (Day 15-30) [Approximated time frames]

Study Arms (2)

Focus Group One

Participants in Focus Group 1 will be assigned a unique study name or pseudonym and requested to answer a set of three different questionnaires that are described in the study's protocol. This study does not involve any type of intervention. The participants will not be administered any type of medications but only questionnaires. This is an observational (cross-section) type of study and not an experimental or randomized clinical trial.

Focus Group Two

Participants in Focus Group 2 will be assigned a unique study name or pseudonym and requested to answer a set of three different questionnaires that are described in the study's protocol. This study does not involve any type of intervention. The participants will not be administered any type of medications but only questionnaires. This is an observational (cross-section) type of study and not an experimental or randomized clinical trial.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African American persons, male and female, 18 years to 90 years that have a history of substance abuse disorder and have competed rehabilitation and not actively using illicit drugs.

You may qualify if:

  • At least 18 years of age
  • Self-identified as Black American or of African American heritage
  • Is using and looking to stop or reduce their cocaine use and or other illicit substance use
  • Has access to device for virtual meetings
  • Able to provide informed consent and complete verbal study assessments in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75703, United States

Location

Related Publications (5)

  • Magruder KM, Bichun Ouyang, Miller S, Tilley BC. Retention of under-represented minorities in drug abuse treatment studies. Clin Trials. 2009 Jun;6(3):252-60. doi: 10.1177/1740774509105224.

    PMID: 19528134RESULT

  • Byrne MM, Tannenbaum SL, Gluck S, Hurley J, Antoni M. Participation in cancer clinical trials: why are patients not participating? Med Decis Making. 2014 Jan;34(1):116-26. doi: 10.1177/0272989X13497264. Epub 2013 Jul 29.

    PMID: 23897588RESULT

  • Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004 Jun 9;291(22):2720-6. doi: 10.1001/jama.291.22.2720.

    PMID: 15187053RESULT

  • Hedegaard H, Spencer MR, Garnett MF. Increase in Drug Overdose Deaths Involving Cocaine: United States, 2009-2018. NCHS Data Brief. 2020 Oct;(384):1-8.

    PMID: 33054918RESULT

  • Hayen A, Wanigasekera V, Faull OK, Campbell SF, Garry PS, Raby SJM, Robertson J, Webster R, Wise RG, Herigstad M, Pattinson KTS. Opioid suppression of conditioned anticipatory brain responses to breathlessness. Neuroimage. 2017 Apr 15;150:383-394. doi: 10.1016/j.neuroimage.2017.01.005. Epub 2017 Jan 3.

    PMID: 28062251RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 17, 2021

Study Start

April 1, 2022

Primary Completion

December 1, 2022

Study Completion

July 31, 2024

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)