Examination of Transcranial Focused Ultrasound on Brain Activity in Adults With Cocaine Use Disorder

NCT07852923 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STUDY25060111UH3DA060431
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to examine the effect of transcranial focused ultrasound (tFUS) on brain activity and cocaine craving in adults with cocaine use disorder.

Conditions

Cocaine Use Disorder (CUD)

Keywords

transcranial focused ultrasound; Magnetic Resonance Imaging; Reward

Outcome Measures

Primary Outcomes (4)

• Ventral striatum (VS) activity to cocaine cues before receiving tFUS to the VS

  Measure of Ventral striatum (VS) activity to cocaine cues before receiving tFUS to the VS

  Two visits over up to 8 weeks

• Ventral striatum (VS) activity to cocaine cues after receiving tFUS to the VS

  Measure of Ventral striatum (VS) activity to cocaine cues after receiving tFUS to the VS

  Two visits over up to 8 weeks

• Cocaine craving before receiving tFUS to the Ventral Striatum (VS)

  The Cocaine Craving Questionnaire-Now (CCQ-Now) is a 45-item self-report measure of current cocaine craving. Each item is rated on a 7-point Likert scale. A total score is calculated by summing all items (after reverse-scoring applicable items per the scoring manual), with possible scores ranging from 45 to 315. Higher total scores indicate greater current craving for cocaine, while lower scores indicate less craving. The questionnaire assesses multiple dimensions of craving, including desire to use cocaine, anticipation of positive effects, anticipation of relief from withdrawal or negative mood, intention or planning to use cocaine, and perceived control over cocaine use. Only the total CCQ-Now score will be analyzed and reported for this outcome.

  Two visits over up to 8 weeks

• Cocaine craving after receiving tFUS to the Ventral Striatum (VS)

  The Cocaine Craving Questionnaire-Now (CCQ-Now) is a 45-item self-report measure of current cocaine craving. Each item is rated on a 7-point Likert scale. A total score is calculated by summing all items (after reverse-scoring applicable items per the scoring manual), with possible scores ranging from 45 to 315. Higher total scores indicate greater current craving for cocaine, while lower scores indicate less craving. The questionnaire assesses multiple dimensions of craving, including desire to use cocaine, anticipation of positive effects, anticipation of relief from withdrawal or negative mood, intention or planning to use cocaine, and perceived control over cocaine use. Only the total CCQ-Now score will be analyzed and reported for this outcome.

  Two visits over up to 8 weeks

Study Arms (2)

VS tFUS/Sham tFUS

EXPERIMENTAL

VS tFUS (tFUS applied to the ventral striatum); Sham tFUS (go through the motions of applying tFUS to the VS)

Device: tFUS; Device: Sham tFUS

Sham tFUS/VS tFUS

EXPERIMENTAL

Sham tFUS (go through the motions of applying tFUS to the VS); VS tFUS (tFUS applied to the ventral striatum)

Device: tFUS; Device: Sham tFUS

Interventions

tFUS DEVICE

tFUS is a brief stimulation of a part of the brain called the ventral striatum with low-intensity sound waves that pass through the scalp and skull safely.

Sham tFUS/VS tFUS; VS tFUS/Sham tFUS

Sham tFUS DEVICE

Sham tFUS goes through the motions of applying tFUS to the brain. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Sham tFUS/VS tFUS; VS tFUS/Sham tFUS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18-45 years of age
• Uses cocaine as a primary drug at a minimum frequency of 1x/mo; any period of abstinence within the past month does not exceed 1 week

You may not qualify if:

• Not between 18-45 years of age
• Cocaine is not used as a primary drug, is used at a frequency of less than 1x/mo, and/or a period of abstinence lasting longer than 1 week has occurred within past month
• Present/lifetime history of primary psychosis or Bipolar Disorder (DSM-5 criteria, SCID-5, SCID-5-PD, YMRS\>10), present suicidal ideation, or current depressive episode
• History of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report)
• Family history of epilepsy
• Use of substances with seizure risk (e.g., stimulants), benzodiazepines, and dopaminergic psychotropic medications in the past month
• Mini-Mental State Examination (MMSE) score (cognitive state) \<24
• Premorbid NAART IQ estimate \<85
• Visual disturbance: \<20/40 Snellen visual acuity
• Left/mixed handedness (Annett criteria)
• Binge drinking (as defined by NIAA criteria: consuming 5 or more drinks (male), or 4 or more drinks (female), in about 2 hours.) in the week before, and/or \>3 drinks/day for the 3 days before, and/or alcohol in the last 12 hrs before, any alcohol on tFUS scan day, confirmed at screening and scan days (to avoid tFUS during alcohol withdrawal). Alcohol/nicotine/caffeine/cannabis use (below SCID-5 SUD and binge levels) will be allowed
• Unable to understand English
• Any implanted neural device since it is not known whether tFUS would interfere with other implanted neural devices
• Color blind

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Mary Phillips, MD MD (Cantab): lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Mary L Phillips

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After each submission cycle, NDA conducts quality assurance (QA) procedures on submitted data during which access to data and images for research is temporarily suspended, typically a period lasting 4 months prior to sharing. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid findability. We will include DOI in relevant publications. NDA will decide how long to preserve the data, but has not deleted any deposited data to date.
• Access Criteria: To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.

Locations

US (1)