NCT05507814

Brief Summary

The primary objective is to test the theory of Reinforcer Pathology via manipulation of the temporal window with successive Episodic Future Thinking generation in individuals with cocaine use disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2025

Completed
Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

August 5, 2022

Last Update Submit

December 1, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in Delay Discounting

    Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks. Change in discounting rates will be compared within-subjects across sessions and between groups.

    Over four-weeks of participation (Weekly for four weeks)

  • Change in Cocaine Demand

    Intensity and elasticity of cocaine demand will be determined from a cocaine demand curve via a Cocaine Purchase Task (CPT). Change in cocaine demand will be compared within-subjects across sessions and between groups.

    Over four weeks of participation (Weekly for four weeks)

  • Cocaine Craving

    The Desires for Drug Questionnaire (DDQ) will be used to assess instant craving for cocaine. Change in cocaine craving will be compared within-subjects across sessions and between groups.

    Over four weeks of participation (Weekly for four weeks)

  • Neural activation during fMRI delay discounting task

    Brain maps will be compared between groups and time points.

    Over four weeks of participation (Baseline, Week 1, Week 4)

  • Neural activation during fMRI cocaine purchase task

    Brain maps will be compared between groups and time points.

    Over four weeks of participation (Baseline, Week 1, Week 4)

Secondary Outcomes (2)

  • Daily Cocaine Use

    Over four weeks of participation

  • Cocaine Urinalysis

    Over four weeks of participation

Study Arms (2)

Episodic Future Thinking (EFT)

EXPERIMENTAL

Participants will generate positive future events they are looking forward to at several time points in the future (e.g., 2 weeks, 1 month, 3 months, 1 year, and 5 years). Participants will be reminded of these events using cues throughout the study and instructed to think about these cues as they make their decisions. This intervention will be tested in both the presence and absence of stress probes.

Behavioral: Episodic Future Thinking (EFT)

Control Episodic Thinking (CET)

SHAM COMPARATOR

Participants will generate positive recent past events that have happened to them at several time points in the previous day (e.g., 7pm-10pm, 4pm-7pm, 1pm-4pm, 10am-1pm, and 7am-10am). Participants will be reminded of these events using cues throughout the study and instructed to think about these cues as they make their decisions. This intervention will be tested in both the presence and absence of stress probes.

Behavioral: Control Episodic Thinking

Interventions

Participants will generate descriptions of vivid positive future events.

Also known as: EFT
Episodic Future Thinking (EFT)

Participants will generate descriptions of vivid positive future events.

Also known as: CET
Control Episodic Thinking (CET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • demonstrate recent cocaine use and CUD (use in last month, DSM-5 for CUD \> 4)
  • be 18 years of age or older
  • have a desire to quit or cut down on their cocaine use, but do not have proximate plans to enroll in treatment for CUD during the study period

You may not qualify if:

  • meeting moderate to severe DSM-5 criteria for opioid use disorder
  • having a current diagnosis of any psychotic disorder
  • having a history of seizure disorders or traumatic brain injury
  • having any contraindication for participation in the MRI sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

Study Officials

  • Stephen LaConte, PhD

    Virginia Polytechnic and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The experimental group will compare episodic future thinking (EFT) to the control group, control episodic thinking (CET).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 19, 2022

Study Start

November 30, 2022

Primary Completion

November 24, 2025

Study Completion

November 24, 2025

Last Updated

December 2, 2025

Record last verified: 2025-12

Locations