Cocaine Use DisorderNCT07091877
Cocaine Cue-reactivity Incubation Study
A study testing Cognitive Reappraisal in people with Cocaine Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
In this study, the research team proposes to longitudinally assess incubation of cue-reactivity, its reduction with cognitive reappraisal (CR; a self-regulation technique) and examine the impact of CR on clinical outcomes in individuals with cocaine use disorder (CUD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Cognitive Reappraisal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and give informed consent
- Age 18-65
- DSM-5 Diagnosis of CUD (Cocaine Use Disorder)
- Have appropriate abstinence duration (i.e., <2 months) at the first visit.
- Must be seeking treatment for CUD (at the first visit)
Who cannot join
- DSM-5 diagnosis for other psychiatric illnesses (other than mood and anxiety disorders that are highly comorbid with substance use disorders)
- Urine positive for any psychoactive drugs (e.g., cocaine, methamphetamine, cannabis, opiates, benzodiazepines, etc.) at baseline
- Head trauma with loss of consciousness
- History of neurological diseases, including seizures
- Thick and/or non-removable hair braids that present difficulty for EEG electrode-scalp contact
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Muhammad A Parvaz, 212-241-3638, muhammad.parvaz@mssm.edu
Muhammad A Parvaz
About this study
Official title: Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity
In this study, the research team proposes to longitudinally assess incubation of cue-reactivity, its reduction with cognitive reappraisal (CR; a self-regulation technique) and examine the impact of CR on clinical outcomes in individuals with cocaine use disorder (CUD). The primary objective is to use psychophysiological markers for tracking brain activity and behavior and changes therein with the use of CR during abstinence in CUD. The secondary objective is to examine whether brain and behavioral changes are associated with clinical outcomes in individuals with CUD. The primary endpoint is the time-related change in brain and behavioral indices with CR during abstinence in individuals with CUD. The secondary endpoint is the impact of CR-mediated changes on clinical outcomes of individuals with CUD.
In this 5-yearlong study the research team will recruit 252 individuals seeking-treatment for CUD, 126 of whom will be randomly assigned to complete the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation (CR+ group), and the other 126 will be assigned to complete a Control task at the same time points (CR- group). All individuals between the ages of 18 and 65 years, irrespective of sex and sexual orientation will be recruited. Participation in the research study will be 5 sessions taking place (one at 2 weeks from screening, one at a month from screening, one at 3 months from screening, one at 5 months from screening, and one the month after the 5 month session) over the course of 6 months.
The study will include EEG testing and will be administered multiple times over the course of 6 months. Participants will be randomized to one of the two groups; one group will get the Cognitive Reappraisal (CR+) intervention and the other group will get a Control intervention (CR-).
- Conditions
- Cocaine Use Disorder
- Being tested
- Cognitive Reappraisal, Control cue-reactivity task
- Keywords
- Cocaine, Craving, EEG, Cue-reactivity, Cognitive reappraisal, Incubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive ReappraisalBehavioural
Cognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task.
Control cue-reactivity taskBehavioural
Participants will complete a control cue-reactivity task.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Reappraisal (CR+) | Experimental | Participants in this arm will complete the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation. Receives: Behavioral: Cognitive Reappraisal |
| No Cognitive Reappraisal (CR-) | Sham comparator | Participants in this arm will complete a control cue-reactivity task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation. Receives: Behavioral: Control cue-reactivity task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Late Positive Potential (LPP) amplitude
EEG-derived Late Positive Potential (LPP) amplitude will be measured while participants view cocaine-related cues. Higher amplitudes indicate greater cue reactivity.
Measured: <2 months, 3 months, and 5 months after abstinence initiation
Secondary outcomes (2)
Change in Late Positive Potential (LPP) amplitude with CR
EEG-derived Late Positive Potential (LPP) amplitude changes during cocaine cue exposure while using cognitive reappraisal techniques.
Measured: <2 months, 3 months, and 5 months after abstinence initiation
Changes in cocaine abstinence duration
Cocaine abstinence (measured in number of days) will be assessed via Timeline Followback Calendar, which tabulates the number of days cocaine was used in the past 90 days.
Measured: <2 months, 3 months, and 5 months after abstinence initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start15 Dec 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Muhammad Parvaz, Icahn School of Medicine at Mount Sinai
- Investigators
- Muhammad A Parvaz, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091877
- Sponsor's protocol ID
- STUDY-22-01618
- Other IDs
- R01DA058039
- Status last verified
- Dec 2024
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Reappraisal for Mitigating Incubation of Cocaine Cue-Reactivity
- ClinicalTrials.gov ID
- NCT07091877
- Acronym / sponsor ID
- STUDY-22-01618
- Conditions
- Cocaine Use Disorder
- Keywords
- Cocaine, Craving, EEG, Cue-reactivity, Cognitive reappraisal, Incubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Jul 2025 (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.
In this study, the research team proposes to longitudinally assess incubation of cue-reactivity, its reduction with cognitive reappraisal (CR; a self-regulation technique) and examine the impact of CR on clinical outcomes in individuals with cocaine use disorder (CUD). The primary objective is to use psychophysiological markers for tracking brain activity and behavior and changes therein with the use of CR during abstinence in CUD. The secondary objective is to examine whether brain and behavioral changes are associated with clinical outcomes in individuals with CUD. The primary endpoint is the time-related change in brain and behavioral indices with CR during abstinence in individuals with CUD. The secondary endpoint is the impact of CR-mediated changes on clinical outcomes of individuals with CUD.
In this 5-yearlong study the research team will recruit 252 individuals seeking-treatment for CUD, 126 of whom will be randomly assigned to complete the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation (CR+ group), and the other 126 will be assigned to complete a Control task at the same time points (CR- group). All individuals between the ages of 18 and 65 years, irrespective of sex and sexual orientation will be recruited. Participation in the research study will be 5 sessions taking place (one at 2 weeks from screening, one at a month from screening, one at 3 months from screening, one at 5 months from screening, and one the month after the 5 month session) over the course of 6 months.
The study will include EEG testing and will be administered multiple times over the course of 6 months. Participants will be randomized to one of the two groups; one group will get the Cognitive Reappraisal (CR+) intervention and the other group will get a Control intervention (CR-).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Reappraisal (CR+) | Experimental | Behavioral: Cognitive ReappraisalParticipants in this arm will complete the Cognitive Reappraisal task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation. |
| No Cognitive Reappraisal (CR-) | Sham comparator | Behavioral: Control cue-reactivity taskParticipants in this arm will complete a control cue-reactivity task repeatedly at 2 weeks, 1-2 months, 3 months, and 5 months after abstinence initiation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to understand and give informed consent
- Age 18-65
- DSM-5 Diagnosis of CUD (Cocaine Use Disorder)
- Have appropriate abstinence duration (i.e., <2 months) at the first visit.
- Must be seeking treatment for CUD (at the first visit)
Key exclusion criteria (5 listed)
- DSM-5 diagnosis for other psychiatric illnesses (other than mood and anxiety disorders that are highly comorbid with substance use disorders)
- Urine positive for any psychoactive drugs (e.g., cocaine, methamphetamine, cannabis, opiates, benzodiazepines, etc.) at baseline
- Head trauma with loss of consciousness
- History of neurological diseases, including seizures
- Thick and/or non-removable hair braids that present difficulty for EEG electrode-scalp contact
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 |
|---|---|---|
| Cognitive ReappraisalCognitive Reappraisal (CR) is a cognitive-behavioral technique and will complete the Cognitive Reappraisal task. | Behavioural | Cognitive Reappraisal (CR+) |
| Control cue-reactivity taskParticipants will complete a control cue-reactivity task. | Behavioural | No Cognitive Reappraisal (CR-) |
Primary outcome
Change in Late Positive Potential (LPP) amplitude
Time frame: <2 months, 3 months, and 5 months after abstinence initiation
EEG-derived Late Positive Potential (LPP) amplitude will be measured while participants view cocaine-related cues. Higher amplitudes indicate greater cue reactivity.
2 secondary outcomes
Change in Late Positive Potential (LPP) amplitude with CR
Time frame: <2 months, 3 months, and 5 months after abstinence initiation
Changes in cocaine abstinence duration
Time frame: <2 months, 3 months, and 5 months after abstinence initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Muhammad A Parvaz, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Reappraisal in people with Cocaine Use Disorder, run by Icahn School of Medicine at Mount Sinai 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad A Parvaz, PhD (212-241-3638, muhammad.parvaz@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Late Positive Potential (LPP) amplitude (time frame: <2 months, 3 months, and 5 months after abstinence initiation). 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 29 Jul 2025.