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Temporal Window and Episodic Future Thinking in CUD

Virginia Polytechnic Institute and State University logo

Virginia Polytechnic Institute and State University

Status

Completed

Conditions

Cocaine Use Disorder

Treatments

Behavioral: Control Episodic Thinking
Behavioral: Episodic Future Thinking (EFT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05507814
VT IRB #22-529

Details and patient eligibility

About

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.

Full description

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.

Enrollment

141 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. demonstrate recent cocaine use and CUD (use in last month, DSM-5 for CUD > 4)
  2. be 18 years of age or older
  3. 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

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

141 participants in 2 patient groups

Episodic Future Thinking (EFT)
Experimental group
Description:
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.
Treatment:
Behavioral: Episodic Future Thinking (EFT)
Control Episodic Thinking (CET)
Sham Comparator group
Description:
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.
Treatment:
Behavioral: Control Episodic Thinking

Trial contacts and locations

1

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Central trial contact

Kirstin Gatchalian

Data sourced from clinicaltrials.gov

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