Clinical trial NCT05507814: Temporal Window and Episodic Future Thinking in CUD
Official title: Test Reinforcer Pathology Via Manipulation of the Temporal Window With Successive Episodic Future Thinking Generation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cocaine Use Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: Carilion Clinic
First posted: 2022-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will compare episodic future thinking (EFT) to the control group, control episodic thinking (CET).
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Delay Discounting
timeFrame: Over four-weeks of participation (Weekly for four weeks)
measure: Change in Cocaine Demand
timeFrame: Over four weeks of participation (Weekly for four weeks)
measure: Cocaine Craving
timeFrame: Over four weeks of participation (Weekly for four weeks)
measure: Neural activation during fMRI delay discounting task
timeFrame: Over four weeks of participation (Baseline, Week 1, Week 4)
measure: Neural activation during fMRI cocaine purchase task
timeFrame: Over four weeks of participation (Baseline, Week 1, Week 4)
Secondary outcomes:
measure: Daily Cocaine Use
timeFrame: Over four weeks of participation
measure: Cocaine Urinalysis
timeFrame: Over four weeks of participation
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
affiliation: Virginia Polytechnic and State University
name: Stephen LaConte, PhD
role: PRINCIPAL_INVESTIGATOR
References: