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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07490600
Status
Recruiting
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Conditions

  • Cocaine Use Disorder (CUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.
  • 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.

Study Details

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

Key Dates

Start date
Apr 21, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CM for 2 weeks then CM only
  • Sham Comparator: CM for 2 weeks, then TMS sham plus CM
  • Experimental: CM for 2 weeks, then TMS experimental plus CM

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Joy M Schmitz, PhD
[email protected]
(713) 486-2867
Jessica Vincent
[email protected]
713 486 2803

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