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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMary Phillips, MD MD (Cantab)

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

    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

Treatment groups

57 Participants
are divided into 2 treatment groups
Group A: VS tFUS/Sham tFUSExperimental treatment 2 interventions
Group B: Sham tFUS/VS tFUSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Two visits over up to 8 weeks
2

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

Time frame
Two visits over up to 8 weeks
3

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.

Time frame
Two visits over up to 8 weeks
4

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.

Time frame
Two visits over up to 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mary Phillips, MD MD (Cantab)

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: