Contingency Management for Meth in South Africa Methamphetamine Abuse in South Africa

Combating Craving With Contingency Management: Neuroplasticity and Methamphetamine Abuse in South Africa

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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Abuse
• Intervention / Treatment: Behavioral: Contingency Management

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 7925
    • Department of Psychiatry at Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management; In exchange for consecutive urine samples documenting methamphetamine abstinence, participants receive increasingly valuable reinforcers.	Behavioral: Contingency Management; as described above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responses to Contingency Management	urine samples documenting methamphetamine abstinence	8 weeks
fMRI Measures	measures of resting state connectivity	Change b/w baseline and 8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stop Signal Task	measure of inhibitory control	Change b/w baseline and 8 Weeks
Continuous Performance Task	test of sustained attention	Change b/w baseline and 8 Weeks
Stroop	test of inhibitory control	Change b/w baseline and 8 Weeks
Balloon Analog Risk Task	measure of risk taking and decision making	Change b/w baseline and 8 Weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: R21CMinSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Data will be shared with other investigators following publication of the main paper or 2 years after the last subject completes participation, whichever comes first. Shared data will be stripped of all PHI and potentially personally identifying variables.

Requests should briefly state the concept of interest, provide a brief timeline for analyzing the data and preparing a manuscript, and include a copy of the CV of the investigator making the request and documentation of proof of training in the ethical treatment of human subjects in research.

The concept proposal will be evaluated based on three criteria, including the potential impact or contribution to the research in advancing knowledge; the feasibility of the proposed research; and that the aim of the proposed research will not overlap with any of the aims or planned analyses.