Contingency Management Plus Deep Transcranial Magnetic Stimulation for the Treatment of Cocaine Use Disorder

Contingency Management Plus Deep Transcranial Magnetic Stimulation for the Treatment

The purpose of this study is to evaluate the effects of Contingency Management (CM)+transcranial magnetic stimulation (TMS) on treatment outcomes in individuals who are initial non-responders and to evaluate the effects of CM+TMS on putative mechanisms of change

Study Overview

• Status: Recruiting
• Conditions: Cocaine Use Disorder (CUD)
• Intervention / Treatment: Behavioral: Contingency Management (CM); Device: Transcranial Magnetic Stimulation (TMS) Sham; Device: Transcranial Magnetic Stimulation (TMS) experimental

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joy M Schmitz, PhD; Phone Number: (713) 486-2867; Email: Joy.M.Schmitz@uth.tmc.edu
• Study Contact Backup: Name: Jessica Vincent; Phone Number: 713 486 2803; Email: Jessica.N.Vincent@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Joy M Schmitz, PhD; Phone Number: (713) 486-2867; Email: Joy.M.Schmitz@uth.tmc.edu
      • Contact: Jessica Vincent; Phone Number: 713 486 2803; Email: Jessica.N.Vincent@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for moderate-to-severe CUD and report recent cocaine use (verified by at least one positive urine drug screen (UDS) for the cocaine metabolite benzoylecgonine (BE), during intake).
• Agree (if the participant is female and of child-bearing potential) to use effective contraceptive methods, unless the participant's male partner(s) is surgically sterile (underwent vasectomy).

Acceptable contraceptives include:

1. oral contraceptives
2. contraceptive sponge
3. patch
4. double barrier (diaphragm/spermicidal or condom/spermicidal)
5. intrauterine contraceptive system
6. etonogestrel implant
7. medroxyprogesterone acetate contraceptive injection
8. complete abstinence from sexual intercourse
9. hormonal vaginal ring

Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.

• Women of child-bearing potential must provide negative urine pregnancy test prior to randomization.
• Be able to provide the names and contact information of at least 2 persons who can consistently locate their whereabouts

Exclusion Criteria:

• Current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, cannabis, or nicotine or a substance Use Disorder (SUD) requiring medical detoxification (e.g., alcohol, opioid, benzodiazepine)
• Presence of any medical, neurological, psychiatric, or physical condition, disease, or illness (including psychosis and bipolar disorder) that, in the opinion of the PIs and the Certified Registered Nurse Anesthetist (CNRA)Medical Director could: (a) compromise interfere, limit, or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data.

• Has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments:

  1. Structured Clinical Interview for DSM-5 (SCID-5)
  2. Columbia-Suicide Severity Rating Scale - Answers YES to Questions 3, 4, 5, or 6
  3. Assault & Homicidal Danger Assessment Tool - Key to Danger > 1
• Any contraindications to MRI scans (metal in the body; claustrophobia). -Medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps, electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil).
• History of brain surgery.
• History of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
• Moderate-to-severe heart disease.
• History of stroke.

• Taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the study physician; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:

  1. clozapine
  2. chlorpromazine
  3. bupropion
  4. clomipramine hydrochloride
  5. amoxapine
  6. maprotiline hydrochloride
  7. diphenhydramine
  8. stimulants other than cocaine including the following:
  9. Dextroamphetamine and amphetamine ii. Dextroamphetamine iii. Lisdexamfetamine dimesylate iv. Methamphetamine

  v. Methylphenidate i. tramadol j. isoniazid.

• Personal history of epilepsy or seizure disorder and/or family history including a first degree relative
• Serious head injury with loss of consciousness
• Having conditions of probation or parole requiring reports of drug use to officers of the court or impending incarceration
• For adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturition, or posture).
• Pregnant or nursing for female participants
• Inability to read, write, or speak English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM for 2 weeks then CM only	Behavioral: Contingency Management (CM); Participants will have thrice-weekly (Monday, Wednesday and Friday) clinic visits, during which participants can earn rewards for submitting a cocaine-negative UDS.CM sessions will consist of the following components: 1) brief discussion of any substance use/cravings since prior CM session; 2) verification that the target behavior (abstinence) was achieved; 3) if achieved, provide incentives and discuss individual plans to use the earnings; 4) if not achieved, review the goals of CM and plans to continue engaging in treatment.
Sham Comparator: CM for 2 weeks, then TMS sham plus CM	Behavioral: Contingency Management (CM); Participants will have thrice-weekly (Monday, Wednesday and Friday) clinic visits, during which participants can earn rewards for submitting a cocaine-negative UDS.CM sessions will consist of the following components: 1) brief discussion of any substance use/cravings since prior CM session; 2) verification that the target behavior (abstinence) was achieved; 3) if achieved, provide incentives and discuss individual plans to use the earnings; 4) if not achieved, review the goals of CM and plans to continue engaging in treatment.; Device: Transcranial Magnetic Stimulation (TMS) Sham; The sham stimulations with negligible induced electric fields, delivered via the same H4 coil to mimic the acoustic characteristics and scalp sensations of active H4 will be used.
Experimental: CM for 2 weeks, then TMS experimental plus CM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who test negative for cocaine use as assessed by urine drug screen	this will be measured measured 3 times per week throughout the study	from Baseline to Week 11
Cocaine craving as assessed by cocaine craving questionnaire (CCQ)	this will be administered weekly. This is a 45 item questionnaire and each is scored on a Likert scale from 1( strongly disagree), to 7(strongly agree). Score range is 45 (minimum) - 315 (maximum).Higher scores indicate greater cocaine craving.	from Baseline to Week 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cue-induced craving as assessed by VAS during cue task	Cue-induced craving will be assessed with a 100-pt Visual Analogue Scale (VAS) that will ask "How much are you craving cocaine right now?" before and after exposure to an EEG Picture Viewing Task that will display cocaine, emotional, and neutral images. Higher score indicates more craving.	Baseline, Week 2, Week 11
Change in amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG	The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.	Baseline, Week 2, Week 11
Change in Functional Connectivity between the Bilateral anterior insula (AIn) and central amygdala (CeA) as measured by Functional Magnetic Resonance Imaging (fMRI)	Functional connectivity between bilateral anterior insula and central amygdala regions will be quantified using resting-state functional magnetic resonance imaging and seed-based connectivity analysis.	Baseline, Week 2, Week 11
Change in Phenotype assessment battery (PhAB) as assessed by addiction domains of cognition, reward, and negative emotionality	The Phenotype Assessment Battery (PhAB) assesses addiction-related domains including cognition, reward processing, and negative emotionality using a standardized battery of behavioral tasks and self-report measures. Individual measure scores are calculated according to established scoring procedures and converted to standardized scores. Standardized scores within each domain are combined to generate domain-specific composite scores. Composite scores are continuous measures without a fixed range, with higher scores indicating greater impairment within the respective domain.	Baseline, Week 2, Week 11

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Joy M Schmitz, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cocaine; Crack; Cocaine treatment
• Additional Relevant MeSH Terms: Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: HSC-MS-25-0782; 1U01DA064181-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No