NCT06145698

Brief Summary

The purpose of this research is to evaluate the efficacy of multiple sessions of theta-gamma cross-frequency transcranial alternating current stimulation in patients with methamphetamine (MA) use disorders.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

December 8, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 24, 2023

Last Update Submit

December 6, 2023

Conditions

Amphetamine-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Change of Craving assessed by Visual Analog Scale

    evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.

    baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment

Secondary Outcomes (6)

  • Depression status assessed by Beck Depression Inventory (BDI)

    baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment

  • Anxiety status assessed by Beck Anxiety Inventory (BAI)

    baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment

  • Sleep Quality Assessment

    baseline，0-2 days after treatment，1 months after treatment, 3 months after treatment

  • Brain oscillations

    baseline，within 30 minutes before and after each session of treatment

  • Reward learning

    baseline，0-2 days after treatment, 3 months after treatment

  • +1 more secondary outcomes

Study Arms (2)

Experimental: theta-gamma tACS

EXPERIMENTAL

The study is investigating the use of transcranial alternating current stimulation (tACS). For the experimental arm, the stimulation is delivered at 2 milliamperes (mA) with the stimulation electrode over the left prefrontal cortex (F3) and left orbitofrontal cortex (Fp1) using the cross-frequency stimulation waveform theta-gamma.

Device: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device

Active-sham tACS

SHAM COMPARATOR

For the active sham stimulation, the stimulation is delivered for 12 seconds with the theta-gamma cross-frequency stimulation waveform and then returns to baseline. The stimulus parameter of the sham stimulation is designed to mimic the adaptive sensations experienced by the subject when receiving the real stimulation treatment settings, but no effective brain modulation will be produced, which assists with blinding the participant's assignment.

Device: Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation device

Interventions

Cross-frequency transcranial alternating current stimulation via the Neuroelectrics Starstim 32 transcranial electric stimulation deviceDEVICE

Stimulation will be delivered via the Neuroelectrics Starstim 32 transcranial electric stimulation device, an investigational electrical non-invasive brain stimulation device that is being used for clinical and translational research.

Active-sham tACSExperimental: theta-gamma tACS

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
  • Normal vision and hearing
  • Dextromanual
  • Use MA not less than 1 year, and the last of MA use no less than 3 months

You may not qualify if:

  • Have a disease that affects cognitive function such as a history of head injury, cerebrovascular disease, epilepsy, etc
  • Have cognitive-promoting drugs in the last 6 months
  • Other substance abuse or dependence in recent five years (except nicotine)
  • Meet the DSM-5 criteria for other mental disorders
  • Physical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Compulsory Rehabilitation Center

Wuhan, 430000, China

RECRUITING

MeSH Terms

Conditions

Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Min Zhao, PhD

    Shanghai Mental Health Center

    STUDY DIRECTOR

Central Study Contacts

Min Zhao, PhD

CONTACT

021-5425268918017311005@163.com

Tianzhen Chen, PhD

CONTACT

+862134773146vomchan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 24, 2023

Study Start

October 15, 2023

Primary Completion

January 15, 2024

Study Completion

February 15, 2024

Last Updated

December 8, 2023

Record last verified: 2023-10

Locations

CN(1)