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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02907853
Other study ID # R21CMinSA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2015
Est. completion date February 15, 2018

Study information

Verified date May 2019
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will link findings from neuroscience with clinical outcomes using contingency management (CM) to identify changes in brain structure and function that emerge during purely behavioral therapy for methamphetamine (MA) use.


Description:

This study will correlate MA-abstinence outcomes from an 8-week program of voucher-based incentives using an escalating schedule for 30 treatment-seeking, MA-dependent individuals with scores on tasks of working memory and assessments of neuropsychological and demographic status. At the beginning and end of the CM program, participants will participate in MRI scans while performing a working memory task and will complete a battery of select neurocognitive and psychological assays to address two specific aims: (1) to determine whether changes in neural function within frontostriatal circuitry from baseline to end of the 8-week CM program are associated with parallel changes in measures of cognitive control and impulsivity and with MA abstinence outcomes and (2) to determine whether structural changes in frontostriatal circuitry over the 8-week CM intervention correspond with neurocognitive, psychological and MA abstinence measures.


Other known NCT identifiers
  • NCT02948868

Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 15, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- provide voluntary informed consent

- meet DSM-5 criteria for MA or amphetamine use disorder

- provide at least one urine sample positive for MA/amphetamine metabolites during screening (i.e. prior to the commencement of the study).

- aged 18-45

- right-handed

- English-speaking

Exclusion Criteria:

- currently receiving treatment for stimulant addiction or needing more intensive treatment than outpatient care

- meet DSM-5 criteria for substance use disorder other than nicotine

- unable to attend 4+ visits during the 2-week screening period or to complete measures

- Physical or mental illness that would require intervention that would alter imaging or that would interfere with safe study participation

- pregnant, claustrophobic, or have metal prostheses, cardiac pacemakers, or metal clips that are incompatible with the scanner

- HIV positive status

- unable to comprehend written or spoken English

- currently taking psychiatric medication

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Contingency Management
as described above

Locations

Country Name City State
South Africa Department of Psychiatry at Groote Schuur Hospital Cape Town

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Responses to Contingency Management urine samples documenting methamphetamine abstinence 8 weeks
Primary fMRI Measures measures of resting state connectivity Change b/w baseline and 8 Weeks
Secondary Stop Signal Task measure of inhibitory control Change b/w baseline and 8 Weeks
Secondary Continuous Performance Task test of sustained attention Change b/w baseline and 8 Weeks
Secondary Stroop test of inhibitory control Change b/w baseline and 8 Weeks
Secondary Balloon Analog Risk Task measure of risk taking and decision making Change b/w baseline and 8 Weeks
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