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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
tFUS
DevicetFUS 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
DeviceSham 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
Trial outcomes
Primary outcomes
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
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
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.
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.
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: