NCT02909101

Brief Summary

The purpose of this study is to examine the effects of a cognitive training program in persons with Human Immunodeficiency Virus (HIV) infection who have used cocaine. This study tests the feasibility and preliminary efficacy of a computerized cognitive training program to improve working memory and decrease impulsivity (delay discounting) among HIV-infected individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

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

September 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2019

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

September 16, 2016

Results QC Date

October 4, 2019

Last Update Submit

October 25, 2019

Conditions

Cocaine Use DisordersHIV

Keywords

Working memorycognitive trainingHIVsubstance abuse

Outcome Measures

Primary Outcomes (1)

  • Working Memory Assessed by Domain Deficit Score

    Measured by domain deficit score, which is a continuous measure of overall impairment on the domain. 0 means no impairment and 5 means highest possible impairment.

    Baseline; post-training, approximately 8 weeks

Secondary Outcomes (6)

  • Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)

    Baseline; post-training, approximately 8 weeks

  • Acceptability as Measured by Participant Ratings

    Post-training, approximately 8 weeks

  • Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions

    Post-training, approximately 8 weeks

  • Percent Medication Adherence Across All Antiretroviral Medications

    Baseline; post-training, approximately 8 weeks

  • Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)

    Baseline; post-training, approximately 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Active Cognitive Training (ACT)

EXPERIMENTAL

Participants will complete computerized games designed to enhance working memory. Participants will complete 48 training sessions over 8 weeks.

Device: Active Cognitive Training (ACT)

Control Training (CON)

SHAM COMPARATOR

Participants will complete 48 training sessions over 8 weeks. The control games are not designed to enhance memory.

Device: Control Training (CON)

Interventions

Active Cognitive Training (ACT)DEVICE

Cognitive training games

Also known as: Lumosity
Active Cognitive Training (ACT)
Control Training (CON)DEVICE

Cognitive training games

Also known as: Lumosity
Control Training (CON)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV infection
  • currently on antiretroviral medications for \>3 months
  • cocaine use as defined by crack/cocaine use in the past month, cocaine-type stimulant use disorder, and cocaine as the principal substance of abuse
  • working memory impairment as defined by scoring \>1 standard deviation below the normative mean on at least 2 out of the 3 working memory tests

You may not qualify if:

  • pregnancy
  • English non-fluency or illiteracy
  • \<8th grade education
  • serious neurological disorders including HIV dementia, traumatic brain injury, severe mental illness, or acute psychiatric distress
  • impaired mental status
  • individuals who state they are planning to move away from the area within the next 3 months
  • individuals without stable housing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Sheri Towe
Organization
Duke University School of Medicine
sheri.towe@duke.edu
919-668-4030

Study Officials

  • Christina S. Meade, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 21, 2016

Study Start

March 1, 2017

Primary Completion

February 23, 2019

Study Completion

February 23, 2019

Last Updated

October 30, 2019

Results First Posted

October 30, 2019

Record last verified: 2019-10

Locations

US(1)