Cocaine Use Disorder (CUD)NCT07490600
Contingency Management Plus Deep Transcranial Magnetic Stimulation for the Treatment of Cocaine Use Disorder
A study testing Contingency Management (CM) and Transcranial Magnetic Stimulation (TMS) experimental in people with Cocaine Use Disorder (CUD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder (CUD)
- What is being tested?
- Contingency Management (CM) and Transcranial Magnetic Stimulation (TMS) experimental
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Be able to provide the names and contact information of at least 2 persons who can consistently locate their whereabouts
Who cannot join
- 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
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- 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
- clomipramine hydrochloride
- amoxapine
- maprotiline hydrochloride
- diphenhydramine
- stimulants other than cocaine including the following:
- Dextroamphetamine and amphetamine ii. Dextroamphetamine iii. Lisdexamfetamine dimesylate iv. Methamphetamine
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Joy M Schmitz, PhD, (713) 486-2867, Joy.M.Schmitz@uth.tmc.edu
Jessica Vincent, 713 486 2803, Jessica.N.Vincent@uth.tmc.edu
About this study
Official title: 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
- Conditions
- Cocaine Use Disorder (CUD)
- Being tested
- Contingency Management (CM), Transcranial Magnetic Stimulation (TMS) Sham, Transcranial Magnetic Stimulation (TMS) experimental
- Keywords
- Cocaine treatment, Cocaine, Crack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency Management (CM)Behavioural
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.
Transcranial Magnetic Stimulation (TMS) ShamDevice
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.
Transcranial Magnetic Stimulation (TMS) experimentalDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CM for 2 weeks then CM only | Experimental | Not described Receives: Behavioral: Contingency Management (CM) |
| CM for 2 weeks, then TMS sham plus CM | Sham comparator | Not described Receives: Behavioral: Contingency Management (CM); Device: Transcranial Magnetic Stimulation (TMS) Sham |
| CM for 2 weeks, then TMS experimental plus CM | Experimental | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: from Baseline to Week 11
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start21 Apr 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use Disorder (CUD)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joy Schmitz, The University of Texas Health Science Center, Houston
- Investigators
- Joy M Schmitz, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490600
- Sponsor's protocol ID
- HSC-MS-25-0782
- Other IDs
- 1U01DA064181-01
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Webber HE, Hong LE, Yoon JH, Lane SD, Du X, Suchting R, Weaver MF, Ochiam L, Petrovitch D, Leonard SJ, Vincent J, Schmitz JM. Contingency management plus deep transcranial magnetic stimulation for the treatment of cocaine use disorder: Protocol of a randomized controlled trial. Contemp Clin Trials. 2026 Oct 3:108494. doi: 10.1016/j.cct.2026.108494. Online ahead of print.
PubMed 42829024
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management Plus Deep Transcranial Magnetic Stimulation for the Treatment
- ClinicalTrials.gov ID
- NCT07490600
- Acronym / sponsor ID
- HSC-MS-25-0782
- Conditions
- Cocaine Use Disorder (CUD)
- Keywords
- Cocaine treatment, Cocaine, Crack
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
- oral contraceptives
- contraceptive sponge
Key exclusion criteria (28 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CM for 2 weeks then CM only, CM for 2 weeks, then TMS sham plus CM |
| Transcranial Magnetic Stimulation (TMS) ShamThe 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. | Device | CM for 2 weeks, then TMS sham plus CM |
| Transcranial Magnetic Stimulation (TMS) experimentalParticipants 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. | Device | – |
Primary outcome
Number of participants who test negative for cocaine use as assessed by urine drug screen
Time frame: from Baseline to Week 11
this will be measured measured 3 times per week throughout the study
Cocaine craving as assessed by cocaine craving questionnaire (CCQ)
Time frame: from Baseline to Week 11
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.
4 secondary outcomes
Change in Cue-induced craving as assessed by VAS during cue task
Time frame: 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
Time frame: 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)
Time frame: Baseline, Week 2, Week 11
Change in Phenotype assessment battery (PhAB) as assessed by addiction domains of cognition, reward, and negative emotionality
Time frame: Baseline, Week 2, Week 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 42829024Webber HE, Hong LE, Yoon JH, Lane SD, Du X, Suchting R, Weaver MF, Ochiam L, Petrovitch D, Leonard SJ, Vincent J, Schmitz JM. Contingency management plus deep transcranial magnetic stimulation for the treatment of cocaine use disorder: Protocol of a randomized controlled trial. Contemp Clin Trials. 2026 Oct 3:108494. doi: 10.1016/j.cct.2026.108494. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joy M Schmitz, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management (CM) and Transcranial Magnetic Stimulation (TMS) experimental in people with Cocaine Use Disorder (CUD), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joy M Schmitz, PhD ((713) 486-2867, Joy.M.Schmitz@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who test negative for cocaine use as assessed by urine drug screen (time frame: from Baseline to Week 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07490600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.