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

Substance Addiction Clinical Trial

— CM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02948868
• Other study ID #: R21DA040492
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2016
• Last updated: November 3, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: University of Cape Town
• Contact: Samantha Brooks, PhD
• Phone: +27 (0)21-4045427
• Email: drsamanthabrooks[@]gmail.com
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study will correlate MA-abstinence outcomes from an 8-week contingency management (CM) program of voucher- based incentives using an escalating schedule that has been successfully implemented as an adjunct to MA treatment by the investigators collaborators in the United States. Pre- and post- treatment neuroimaging and neurocognitive assessments will assist in identifying structures and/or processes that may represent targets for development of novel behavioral and/or medication therapies.

Description:

Methamphetamine addiction (MA) is a global health problem with high prevalence and great social and health costs in the United States and in the Republic of South Africa, and there is a strong need for development and implementation of effective MA treatment approaches. This study will correlate MA-abstinence outcomes from an 8-week contingency management (CM) program of voucher- based incentives using an escalating schedule that has been successfully implemented as an adjunct to MA treatment by the investigators collaborators in the United States. Pre- and post- treatment neuroimaging and neurocognitive assessments will assist in identifying structures and/or processes that may represent targets for development of novel behavioral and/or medication therapies.

The study has 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; (2) to determine whether structural changes in frontostriatal circuitry over the 8-week CM intervention correspond with neurocognitive, psychological and MA abstinence measures. Findings from this study will describe associations between: (1) functional and structural indices of brain areas that support working memory, cognitive control/inhibition; (2) performance on select neurocognitive and psychological assessments; and (3) associations between these with MA abstinence outcomes. Study activities and the neuroscience data generated will provide preliminary data for a larger, adequately powered study that will test ways to optimize behavioral therapies for treating stimulant use disorder.

Furthermore, the public health relevance of this study is enhanced by its effort to develop capacity for a productive and impactful neuroscience research agenda between groups of strong clinical scientists in the U.S. and in the Republic of South Africa.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Regular methamphetamine (tik) regularly

• Currently looking for treatment

• Between the ages of 18 and 45

• Right handed

• Not pregnant

• Not HIV positive

Exclusion Criteria:

• Significant physical, psychiatric or neurological illness

• HIV/AIDS positive

• A past history of significant alcohol and/or other substance abuse

• Metal prosthesis

• Cardiac pacemaker

• Metal clips, pins or plates in the participant's body

• Claustrophobia

• Pregnancy

• Currently receiving treatment for stimulant addiction

• Require a more intensive treatment than this outpatient procedure

• Unable to attend the visits required during the study

• Fail to complete any measures or procedures during the study

• Have had a 'serious' head injury

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Addiction
• Substance-Related Disorders

Intervention

Behavioral:
• Contingency Management
Administering of vouchers to methamphetamine users for negative urine samples

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town	Western Cape

Sponsors (2)

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

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study on working memory in methamphetamine to assess a change from baseline to follow up after contingency management as assessed by fMRI	Functional magnetic resonance imaging (fMRI), Resting state, diffusion tensor imaging (DTI)	2 years	No
Secondary	Methamphetamine users assessed for risk taking measures to assess a change from baseline to follow up after contingency management assessed by SPSS	Balloon analogue risk task (BART)	2 years	No
Secondary	Participants assessed for a variant of risk taking analysed by SPSS	Iowa Gambling task	2 years	No
Secondary	Methamphetamine users assessed for working memory in fMRI analysed by SPSS	N-Back	2 years	No
Secondary	Methamphetamine users assessed for impulsivity to assess a change from baseline to follow up after contingency management assessed by SPSS	Continuous performance task (CPT)	2 years	No
Secondary	Participants assessed for a variant of impulsivity and attention analyzed by SPSS	Stop signal task (SST)	2 years	No
Secondary	Methamphetamine users assessed for cognitive function to assess a change from baseline to follow up after contingency management assessed by SPSS	Stroop	2 years	No