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

NCT07490600 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-25-07821U01DA064181-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Use Disorder (CUD)

Keywords

Cocaine treatment; Cocaine; Crack

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Cue-induced craving as assessed by VAS during cue task

  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

  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)

  Baseline, Week 2, Week 11

• Change in Phenotype assessment battery (PhAB) as assessed by addiction domains of cognition, reward, and negative emotionality

  Baseline, Week 2, Week 11

Study Arms (3)

CM for 2 weeks then CM only

EXPERIMENTAL

Behavioral: Contingency Management (CM)

CM for 2 weeks, then TMS sham plus CM

SHAM COMPARATOR

Behavioral: Contingency Management (CM); Device: Transcranial Magnetic Stimulation (TMS) Sham

CM for 2 weeks, then TMS experimental plus CM

EXPERIMENTAL

Interventions

Contingency Management (CM) BEHAVIORAL

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.

CM for 2 weeks then CM only; CM for 2 weeks, then TMS sham plus CM

Transcranial Magnetic Stimulation (TMS) Sham DEVICE

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.

CM for 2 weeks, then TMS sham plus CM

Transcranial Magnetic Stimulation (TMS) experimental DEVICE

Participants will sit comfortably in a chair with head support and wear protective earplugs. A Brainsway Deep TMS system model 104 with an H4 coil will be used. Following the standardized procedure, the H4 coil is held by a mechanical arm and positioned 6 cm anterior to the motor spot.Duration: The proposed H4 coil-delivered accelerated TMS protocol will use iTBS for 3 sessions a day, 3 days a week, for 6 weeks (54 sessions) followed by two weeks of 3 sessions a day (6 additional maintenance sessions). For each iTBS session, bursts of 3 pulses at 50 Hz are repeated at 5 Hz as a train for 2 seconds. The intertrain interval is 8 seconds. There are 20 trains lasting 192 seconds (600 pulses) per session. Each visit day includes 3 iTBS sessions (i.e., accelerated iTBS) 30 minutes apart,96 lasting approximately \~70 minutes per visit.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• oral contraceptives
• contraceptive sponge
• patch
• double barrier (diaphragm/spermicidal or condom/spermicidal)
• intrauterine contraceptive system
• etonogestrel implant
• medroxyprogesterone acetate contraceptive injection
• complete abstinence from sexual intercourse
• 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.

You may not qualify if:

• 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:
• Structured Clinical Interview for DSM-5 (SCID-5)
• Columbia-Suicide Severity Rating Scale - Answers YES to Questions 3, 4, 5, or 6
• 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:
• clozapine
• chlorpromazine
• bupropion

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Joy M Schmitz, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy M Schmitz, PhD

CONTACT

(713) 486-2867; Joy.M.Schmitz@uth.tmc.edu

Jessica Vincent

CONTACT

713 486 2803; Jessica.N.Vincent@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)