Cocaine Use DisorderNCT05507814
Temporal Window and Episodic Future Thinking in CUD
A study testing Episodic Future Thinking (EFT) in people with Cocaine Use Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Episodic Future Thinking (EFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Test Reinforcer Pathology Via Manipulation of the Temporal Window With Successive Episodic Future Thinking Generation.
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.
Read the 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.
- Conditions
- Cocaine Use Disorder
- Being tested
- Episodic Future Thinking (EFT), Control Episodic Thinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Future Thinking (EFT)Behavioural
Also called EFT
Participants will generate descriptions of vivid positive future events.
Control Episodic ThinkingBehavioural
Also called CET
Participants will generate descriptions of vivid positive future events.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control Episodic Thinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over four weeks of participation (Baseline, Week 1, Week 4)
Secondary outcomes (2)
Daily Cocaine Use
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.
Measured: Over four weeks of participation
Cocaine Urinalysis
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.
Measured: Over four weeks of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start30 Nov 2022
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will compare episodic future thinking (EFT) to the control group, control episodic thinking (CET).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Carilion Clinic
- Responsible party
- Principal investigator, Stephen LaConte, Virginia Polytechnic Institute and State University
- Investigators
- Stephen LaConte, PhD, Principal investigator, Virginia Polytechnic and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507814
- Sponsor's protocol ID
- VT IRB #22-529
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test Reinforcer Pathology Via Manipulation of the Temporal Window With Successive Episodic Future Thinking Generation.
- ClinicalTrials.gov ID
- NCT05507814
- Acronym / sponsor ID
- VT IRB #22-529
- Conditions
- Cocaine Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Arizona State University, Carilion Clinic
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The experimental group will compare episodic future thinking (EFT) to the control group, control episodic thinking (CET).
| Arm | Type | Receives |
|---|---|---|
| Episodic Future Thinking (EFT) | Experimental | Behavioral: Episodic Future Thinking (EFT)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. |
| Control Episodic Thinking (CET) | Sham comparator | Behavioral: Control Episodic ThinkingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Episodic Future Thinking (EFT)Also: EFTParticipants will generate descriptions of vivid positive future events. | Behavioural | Episodic Future Thinking (EFT) |
| Control Episodic ThinkingAlso: CETParticipants will generate descriptions of vivid positive future events. | Behavioural | Control Episodic Thinking (CET) |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Daily Cocaine Use
Time frame: Over four weeks of participation
Cocaine Urinalysis
Time frame: Over four weeks of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen LaConte, PhD principal investigator
Virginia Polytechnic and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Future Thinking (EFT) in people with Cocaine Use Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Delay Discounting (time frame: Over four-weeks of participation (Weekly for four weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.