NCT02907853

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

September 13, 2016

Last Update Submit

May 8, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Stop Signal Task

    Change b/w baseline and 8 Weeks

  • Continuous Performance Task

    Change b/w baseline and 8 Weeks

  • Stroop

    Change b/w baseline and 8 Weeks

  • Balloon Analog Risk Task

    Change b/w baseline and 8 Weeks

Study Arms (1)

Contingency Management

EXPERIMENTAL

In exchange for consecutive urine samples documenting methamphetamine abstinence, participants receive increasingly valuable reinforcers.

Behavioral: Contingency Management

Interventions

as described above

Contingency Management

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry at Groote Schuur Hospital

Cape Town, 7925, South Africa

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 20, 2016

Study Start

September 1, 2015

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

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.

Locations