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

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)

Interventions

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.

DEVICE

Transcranial Magnetic Stimulation (TMS) experimental

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Joy M Schmitz, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-21

Primary Completion

2029-06-01

Completion

2029-09-01

FDA Device

Yes

Countries

• United States

Study Locations