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Completed

NCT Number: NCT05507814

Temporal Window and Episodic Future Thinking in CUD

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.

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

Adults with cocaine use disorder will be randomly assigned to experimental or control groups, stratified by polydrug use disorder, SES, and sex. The experimental group will compare episodic future thinking (EFT) to control episodic thinking (CET). The study procedures will include a baseline session (S1) and a 4-week intervention period where participants will return to the lab three times a week. Participants will generate new EFT and CET events at approximately weekly intervals. The EFT or CET events will be texted to them twice daily with urine samples obtained thrice-weekly. To probe resistance to disruption, both groups will receive stress-inducing probes that shorten the temporal window after the first and last cue generation. During the first assessment visit (S2), participants will be randomized with stratification to generate either episodic future thinking (EFT) or control episodic thinking (CET) events and will undergo neuroimaging procedures. At the following session in S3, participants will be randomized to receive one of two stress probes (counterbalanced) or their respective control. Participants will be exposed to a stress probe or control at S3 and the corresponding narrative at the next visit, S4. S5 and S6 will begin with participants generating new EFT/CET events that will be used for that session and the following two sessions. S7, like S2, will begin with EFT/CET event generation and neuroimaging procedures. During the final two sessions (S8, S9), participants will be exposed to the other stress probe and control that they did not see during S3/S4.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Episodic Future Thinking (EFT)

Behavioral

Participants will generate descriptions of vivid positive future events.

Other names: EFT

Control Episodic Thinking

Behavioral

Participants will generate descriptions of vivid positive future events.

Other names: CET

Primary outcomes

  1. Change in Delay Discounting

    Time frame: Over four-weeks of participation (Weekly for four weeks)

    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.

  2. Change in Cocaine Demand

    Time frame: Over four weeks of participation (Weekly for four weeks)

    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.

  3. Cocaine Craving

    Time frame: Over four weeks of participation (Weekly for four weeks)

    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.

  4. Neural activation during fMRI delay discounting task

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

    Brain maps will be compared between groups and time points.

  5. Neural activation during fMRI cocaine purchase task

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

    Brain maps will be compared between groups and time points.

Secondary outcomes

  1. Daily Cocaine Use

    Time frame: Over four weeks of participation

    Daily cocaine use will be assessed via the daily Ecological Momentary Assessments (EMAs). Change in daily cocaine use will be compared within-subjects across the study duration and between groups.

  2. Cocaine Urinalysis

    Time frame: Over four weeks of participation

    Cocaine urinalysis will be measured from the urinalysis collected at sessions and retention check-ins. Change in cocaine urinalysis will be compared within-subjects across the study duration and between groups.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Arizona State University
  • Carilion Clinic

Registry information

Official study title

Test Reinforcer Pathology Via Manipulation of the Temporal Window With Successive Episodic Future Thinking Generation.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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