Methamphetamine AbuseNCT02907853
Contingency Management for Meth in South Africa Methamphetamine Abuse in South Africa
A study testing Contingency Management in people with Methamphetamine Abuse, run by University of California, Los Angeles at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Abuse
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Sep 2015to 15 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Department of Psychiatry at Groote Schuur Hospital
Cape Town, 7925
About this study
Official title: 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.
Read the 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.
- Conditions
- Methamphetamine Abuse
- Being tested
- Contingency Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
as described above
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | In exchange for consecutive urine samples documenting methamphetamine abstinence, participants receive increasingly valuable reinforcers. Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses to Contingency Management
urine samples documenting methamphetamine abstinence
Measured: 8 weeks
fMRI Measures
measures of resting state connectivity
Measured: Change b/w baseline and 8 Weeks
Secondary outcomes (4)
Stop Signal Task
measure of inhibitory control
Measured: Change b/w baseline and 8 Weeks
Continuous Performance Task
test of sustained attention
Measured: Change b/w baseline and 8 Weeks
Stroop
test of inhibitory control
Measured: Change b/w baseline and 8 Weeks
Balloon Analog Risk Task
measure of risk taking and decision making
Measured: Change b/w baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Sep 2015
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Steve Shoptaw, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907853
- Sponsor's protocol ID
- R21CMinSA
- Status last verified
- May 2019
- First submitted
- 13 Sep 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combating Craving With Contingency Management: Neuroplasticity and Methamphetamine Abuse in South Africa
- ClinicalTrials.gov ID
- NCT02907853
- Acronym / sponsor ID
- R21CMinSA
- Conditions
- Methamphetamine Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency ManagementIn exchange for consecutive urine samples documenting methamphetamine abstinence, participants receive increasingly valuable reinforcers. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency Managementas described above | Behavioural | Contingency Management |
Primary outcome
Responses to Contingency Management
Time frame: 8 weeks
urine samples documenting methamphetamine abstinence
fMRI Measures
Time frame: Change b/w baseline and 8 Weeks
measures of resting state connectivity
4 secondary outcomes
Stop Signal Task
Time frame: Change b/w baseline and 8 Weeks
Continuous Performance Task
Time frame: Change b/w baseline and 8 Weeks
Stroop
Time frame: Change b/w baseline and 8 Weeks
Balloon Analog Risk Task
Time frame: Change b/w baseline and 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Methamphetamine Abuse, run by University of California, Los Angeles at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responses to Contingency Management (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.