RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users (ARTEMIS)
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ClinicalTrials.gov Identifier: NCT01926184 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 20, 2013
Last Update Posted
: October 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV/AIDS Stimulant Use Disorders | Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS) Behavioral: Contingency Management (CM) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Trial of an Integrative Intervention for Non-Treatment-Seeking Meth Users |
Actual Study Start Date : | January 2013 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: ARTEMIS+CM
This is a 5-session, individually delivered intervention that is designed to enhance positive affect. It is designed to boost and extend the effectiveness of contingency management (CM).
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Behavioral: Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)
5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).
Behavioral: Contingency Management (CM)
12-week CM protocol that provides escalating monetary reinforcement for biological evidence of methamphetamine abstinence. Delivered as the standard of care for non-treatment-seeking methamphetamine-using MSM in San Francisco. Delivered to both the intervention and attention-control arms
Other Name: Positive Reinforcement Opportunity Project (PROP)
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Placebo Comparator: Attention-Control+CM
Attention-matched, 5-session control condition consisting of brief-self report psychological measures and neutral writing exercises. Contingency management (CM) is also administered to this arm.
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Behavioral: Contingency Management (CM)
12-week CM protocol that provides escalating monetary reinforcement for biological evidence of methamphetamine abstinence. Delivered as the standard of care for non-treatment-seeking methamphetamine-using MSM in San Francisco. Delivered to both the intervention and attention-control arms
Other Name: Positive Reinforcement Opportunity Project (PROP)
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- HIV Viral Load [ Time Frame: 15 Months ]Log10 HIV viral load change and log10 viral load at 15 months
- Sustained HIV viral suppression [ Time Frame: 15 Months ]Sustained HIV viral suppression over the 15-month follow-up period.
- T-helper Count [ Time Frame: 15 Months ]Change in t-helper (CD4+) count
- Methamphetamine and Cocaine Use (Stimulant Use) [ Time Frame: 15 Months ]Changes in methamphetamine and cocaine use (assessed via self-report and urine toxicology screening) over the 15-month follow-up.
- Psychological Adjustment [ Time Frame: 15 Months ]Changes in positive affect, negative affect, and depressive symptoms over the 15-month follow-up.
- Potentially Amplified Transmission (PAT) Risk Behavior [ Time Frame: 15 Months ]Changes in self-reported HIV transmission risk behavior with a detectable HIV viral load (> 200 copies/ml) over the 15-month follow-up.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years old
- Documentation of HIV-positive serostatus
- Speak English
- Biological verification of recent methamphetamine use
- Completion of at least three contingency management (CM) visits
- Self reported anal sex with a man (MSM) in the past 12 months
Exclusion Criteria:
- Inability to provide informed consent, evidenced by cognitive impairment
- HIV negative serostatus

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926184
United States, California | |
Alliance Health Project | |
San Francisco, California, United States, 94102 |
Principal Investigator: | William Woods, Ph.D. | University of California, San Francisco | |
Principal Investigator: | Adam W. Carrico, Ph.D. | Miami University | |
Principal Investigator: | Judith T. Moskowitz, Ph.D., MPH | Northwestern University |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | William Woods, Professor, School of Medicine, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01926184 History of Changes |
Other Study ID Numbers: |
R01DA033854 ( U.S. NIH Grant/Contract ) |
First Posted: | August 20, 2013 Key Record Dates |
Last Update Posted: | October 2, 2017 |
Last Verified: | September 2017 |
Keywords provided by William Woods, University of California, San Francisco:
HIV/AIDS Treatment as Prevention Methamphetamine Cocaine HIV viral Load |
Additional relevant MeSH terms:
Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors |