TY - JOUR
KW - Administration, Intranasal
KW - Adolescent
KW - Adult
KW - Aged
KW - Amphetamine-Related Disorders/diagnosis/psychology/therapy
KW - Central Nervous System Stimulants
KW - Combined Modality Therapy
KW - Double-Blind Method
KW - Homosexuality, Male/psychology
KW - Humans
KW - Male
KW - Methamphetamine
KW - Middle Aged
KW - Motivational Interviewing/methods
KW - Oxytocin/administration & dosage/adverse effects
KW - Psychotherapy, Group/methods
KW - Randomized Controlled Trials as Topic
KW - San Francisco
KW - Sexual and Gender Minorities/psychology
KW - Time Factors
KW - Treatment Outcome
KW - Young Adult
KW - Addiction
KW - Drug-assisted psychotherapy
KW - Group therapy
KW - Men who Have Sex with Men
KW - Meth
KW - methamphetamine use disorder
KW - Motivational Interviewing
KW - Oxytocin
KW - stimulant
AU - C. S. Stauffer
AU - J. M. Moschetto
AU - S. M. McKernan
AU - E. Hsiang
AU - B. Borsari
AU - J. D. Woolley
A1 - 
AB - BACKGROUND: The prevalence of methamphetamine use disorder (MUD) in the United States has risen dramatically in the past four decades and is concentrated in populations such as men who have sex with men (MSM). Despite the public health consequences of MUD, there are no FDA-approved psychopharmacological treatments. Psychosocial treatment alone has been shown to reduce methamphetamine use, but high attrition rates limit treatment efficacy. Promising findings from animal models of MUD using exogenous oxytocin, a social neuropeptide, have set the stage for translational work. Along with unique anti-addiction effects, oxytocin holds a primary role in enhancing social salience and modulating stress. In humans, oxytocin administration, combined with evidence-based psychosocial interventions, may act synergistically to improve addiction treatment outcomes and improve retention rates in current MUD treatment. METHODS/DESIGN: We are conducting a randomized, double-blind, placebo-controlled trial of oxytocin-enhanced motivational interviewing group therapy (MIGT). Oxytocin or placebo 40 IU is administered intranasally in conjunction with six, weekly MIGT sessions. We will recruit 50 MSM, initiating treatment for MUD from specialized community health programs in San Francisco, CA, USA. Individuals will be randomized (1:1) to receive six, weekly sessions of MIGT with or without oxytocin. Our primary outcome is session attendance. Other outcomes of interest include: measures of group cohesion, anxiety, psychophysiology, and stimulant craving and use. DISCUSSION: This will be the first study of oxytocin's effects in humans with MUD. Findings from this novel protocol will attempt to bridge existing animal data with the need for innovative clinical treatments for MUD, inform the growing field of pharmacologically-enhanced psychotherapy, and help to elucidate mechanisms behind oxytocin's potential anti-addiction effects. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02881177 . Registered on 26 August 2016.
AD - University of California, San Francisco, San Francisco VA Medical Center, San Francisco, CA, USA. christopher.stauffer@ucsf.edu.; Palo Alto University, Palo Alto, CA, USA.; University of California, San Francisco, CA, USA.; University of California, San Francisco School of Medicine, San Francisco, CA, USA.; University of California, San Francisco, San Francisco VA Medical Center, San Francisco, CA, USA.; University of California, San Francisco, San Francisco VA Medical Center, San Francisco, CA, USA.
BT - Trials
C5 - Healthcare Disparities; Opioids & Substance Use
CP - 1
DO - 10.1186/s13063-019-3225-7
IS - 1
JF - Trials
LA - eng
M1 - Journal Article
N2 - BACKGROUND: The prevalence of methamphetamine use disorder (MUD) in the United States has risen dramatically in the past four decades and is concentrated in populations such as men who have sex with men (MSM). Despite the public health consequences of MUD, there are no FDA-approved psychopharmacological treatments. Psychosocial treatment alone has been shown to reduce methamphetamine use, but high attrition rates limit treatment efficacy. Promising findings from animal models of MUD using exogenous oxytocin, a social neuropeptide, have set the stage for translational work. Along with unique anti-addiction effects, oxytocin holds a primary role in enhancing social salience and modulating stress. In humans, oxytocin administration, combined with evidence-based psychosocial interventions, may act synergistically to improve addiction treatment outcomes and improve retention rates in current MUD treatment. METHODS/DESIGN: We are conducting a randomized, double-blind, placebo-controlled trial of oxytocin-enhanced motivational interviewing group therapy (MIGT). Oxytocin or placebo 40 IU is administered intranasally in conjunction with six, weekly MIGT sessions. We will recruit 50 MSM, initiating treatment for MUD from specialized community health programs in San Francisco, CA, USA. Individuals will be randomized (1:1) to receive six, weekly sessions of MIGT with or without oxytocin. Our primary outcome is session attendance. Other outcomes of interest include: measures of group cohesion, anxiety, psychophysiology, and stimulant craving and use. DISCUSSION: This will be the first study of oxytocin's effects in humans with MUD. Findings from this novel protocol will attempt to bridge existing animal data with the need for innovative clinical treatments for MUD, inform the growing field of pharmacologically-enhanced psychotherapy, and help to elucidate mechanisms behind oxytocin's potential anti-addiction effects. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02881177 . Registered on 26 August 2016.
PY - 2019
SN - 1745-6215; 1745-6215
SP - 019
EP - 7
EP - 145+
T1 - Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial
T2 - Trials
TI - Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial
U1 - Healthcare Disparities; Opioids & Substance Use
U2 - 30791944
U3 - 10.1186/s13063-019-3225-7
VL - 20
VO - 1745-6215; 1745-6215
Y1 - 2019
Y2 - Feb 21
ER -