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BACKGROUND: Individuals with alcohol use disorder (AUD) are much more likely to meet criteria for posttraumatic stress disorder (PTSD) than the general population. Compared to AUD alone, those with comorbid AUD-PTSD experience worse outcomes. Prior literature suggests that oxytocin, a hypothalamic neuropeptide, may be effective in the treatment of both AUD and PTSD when administered intranasally, although specific mechanisms remain elusive. METHODS: Forty-seven male patients with comorbid AUD-PTSD were administered intranasal oxytocin in a randomized, double-blind, dose-ranging (20 IU, 40 IU, and matched placebo), within-participant design with study visits at least 1 week apart. A cue-induced craving paradigm was conducted using each participant's preferred alcoholic beverage versus a neutral water cue. Self-reported alcohol craving and heart rate (HR) were recorded and analyzed using linear mixed-effect models. RESULTS: While alcohol cues significantly induced self-reported craving and increased HR compared to neutral water cues, neither dosage of oxytocin compared to placebo reduced self-reported cue-induced alcohol craving nor cue-induced changes in HR in patients with PTSD-AUD. CONCLUSIONS: These preliminary findings suggest that oxytocin does not affect cue-induced craving. Our results contribute to an ever-growing field of research investigating the effects of intranasal oxytocin on the symptoms of substance use disorders and will help further refine methodology and streamline future inquiries in this area.
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Alcoholismo/epidemiología , Ansia/efectos de los fármacos , Oxitocina/farmacología , Trastornos por Estrés Postraumático/epidemiología , Administración Intranasal , Alcoholismo/fisiopatología , Alcoholismo/psicología , Comorbilidad , Señales (Psicología) , Método Doble Ciego , Frecuencia Cardíaca/fisiología , Humanos , Masculino , Oxitocina/administración & dosificación , San Francisco/epidemiología , Trastornos por Estrés Postraumático/fisiopatología , Trastornos por Estrés Postraumático/psicologíaRESUMEN
BACKGROUND: Photographic stimuli are commonly used to assess cue reactivity in the research and treatment of alcohol use disorder. The stimuli used are often non-standardized, not properly validated, and poorly controlled. There are no previously published, validated, American-relevant sets of alcohol images created in a standardized fashion. OBJECTIVES: We aimed to: 1) make available a standardized, matched set of photographic alcohol and non-alcohol beverage stimuli, 2) establish face validity, the extent to which the stimuli are subjectively viewed as what they are purported to be, and 3) establish construct validity, the degree to which a test measures what it claims to be measuring. METHODS: We produced a standardized set of 36 images consisting of American alcohol and non-alcohol beverages matched for basic color, form, and complexity. A total of 178 participants (95 male, 82 female, 1 genderqueer) rated each image for appetitiveness. An arrow-probe task, in which matched pairs were categorized after being presented for 200 ms, assessed face validity. Criteria for construct validity were met if variation in AUDIT scores were associated with variation in performance on tasks during alcohol image presentation. RESULTS: Overall, images were categorized with >90% accuracy. Participants' AUDIT scores correlated significantly with alcohol "want" and "like" ratings [r(176) = 0.27, p = <0.001; r(176) = 0.36, p = <0.001] and arrow-probe latency [r(176) = -0.22, p = 0.004], but not with non-alcohol outcomes. Furthermore, appetitive ratings and arrow-probe latency for alcohol, but not non-alcohol, differed significantly for heavy versus light drinkers. CONCLUSION: Our image set provides valid and reliable alcohol stimuli for both explicit and implicit tests of cue reactivity. The use of standardized, validated, reliable image sets may improve consistency across research and treatment paradigms.
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Bebidas Alcohólicas/normas , Bebidas/normas , Fotograbar , Adulto , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
30-60% of patients receiving methadone for opioid use disorder (OUD) actively use cocaine. Cocaine use disorder (CUD) has no FDA-approved pharmacological treatment; existing psychosocial treatments are inadequate. Oxytocin, a social neuropeptide, has preclinical promise as an adjunctive treatment for both OUD and CUD. Twenty-two individuals receiving methadone for OUD with co-occurring CUD were randomized to receive oxytocin or placebo intranasally 40 IU twice daily for two weeks. A priori aims were feasibility and safety. Exploratory effectiveness aims included laboratory-based measures of drug craving, drug-related implicit cognition, and drug use. High retention rates (93.5%), the absence of study-related adverse events, and the fact that oxytocin was well tolerated in this population support the feasibility of larger trials. Two weeks of oxytocin (but not placebo) significantly reduced cocaine craving at day 15 compared to baseline (mean change±SD: OT=-0.23±0.19, p=0.004; PL=-0.16±0.29, p=0.114). For heroin craving, the placebo group reported a trend-level increase over time while the oxytocin group remained unchanged - with medium to large effect sizes between the groups (Cohen's d=0.71-0.90). Oxytocin led to a significant switch from implicit self-association with drugs to implicitly associating drugs with others (mean change±SD: 0.25±0.35, p=0.037) and a trend-level reduction in self-reported cocaine use over time (Z=-1.78, p=0.075). Furthermore, oxytocin significantly increased the accuracy of self-reported cocaine use when correlated with quantitative urine levels of cocaine metabolite. This proof-of-concept study provides promising early evidence that oxytocin may be an effective adjunct to the treatment of co-occurring CUD and OUD. Further investigation with larger trials is warranted.
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BACKGROUND: Voter initiatives in Oregon and Colorado authorize legal frameworks for supervised psilocybin services, but no measures monitor safety or outcomes. AIMS: To develop core measures of best practices. METHODS: A three-phase e-Delphi process recruited 36 experts with 5 or more years' experience facilitating psilocybin experiences in various contexts (e.g., ceremonial settings, indigenous practices, clinical trials), or other pertinent psilocybin expertise. Phase I, an on-line survey with qualitative, open-ended text responses, generated potential measures to assess processes, outcomes, and structure reflecting high quality psilocybin services. In Phase II, experts used seven-point Likert scales to rate the importance and feasibility of the Phase I measures. Measures were priority ranked. Qualitative interviews and analysis in Phase III refined top-rated measures. RESULTS: Experts (n = 36; 53% female; 71% white; 56% heterosexual) reported currently providing psilocybin services (64%) for a mean of 15.2 [SD 13.1] years, experience with indigenous psychedelic practices (67%), and/or conducting clinical trials (36%). Thematic analysis of Phase I responses yielded 55 candidate process measures (e.g., preparatory hours with client, total dose of psilocybin administered, documentation of touch/sexual boundaries), outcome measures (e.g., adverse events, well-being, anxiety/depression symptoms), and structure measures (e.g., facilitator training in trauma informed care, referral capacity for medical/psychiatric issues). In Phase II and III, experts prioritized a core set of 11 process, 11 outcome, and 17 structure measures that balanced importance and feasibility. CONCLUSION: Service providers and policy makers should consider standardizing core measures developed in this study to monitor the safety, quality, and outcomes of community-based psilocybin services.
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Consenso , Alucinógenos , Psilocibina , Psilocibina/farmacología , Psilocibina/administración & dosificación , Humanos , Alucinógenos/administración & dosificación , Alucinógenos/uso terapéutico , Alucinógenos/efectos adversos , Femenino , Masculino , Adulto , Oregon , Colorado , Persona de Mediana Edad , Encuestas y CuestionariosRESUMEN
Methamphetamine use disorder is a chronic relapsing condition associated with substantial mental, physical, and social harms and increasing rates of mortality. Contingency management and psychotherapy interventions are the mainstays of treatment but are modestly effective with high relapse rates, while pharmacological treatments have shown little to no efficacy. Psilocybin-assisted psychotherapy is emerging as a promising treatment for a range of difficult-to-treat conditions, including substance use disorders; however, no studies have yet been published looking at psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder. Here we review the rationale for psilocybin-assisted psychotherapy as a potential treatment for this indication, and describe practical considerations based on our early experience designing and implementing four separate clinical trials of psilocybin-assisted psychotherapy for methamphetamine use disorder.
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Objective: To compare group and individual psychedelic-assisted therapy in terms of clinician time, costs and patient access. Methods: Using 2023 data from two group therapy trial sites, one using 3,4-Methylenedioxymethamphetamine (MDMA) to treat posttraumatic stress disorder (PTSD), and one using psilocybin to treat major depressive disorder (MDD), we compared overall variable costs, clinician costs and clinician time required by therapy protocols utilizing groups versus individual patient therapy. Using published literature, we estimated the prevalence of adults with PTSD and MDD eligible for treatment with psychedelic therapy and projected the savings in time and cost required to treat these prevalent cases. Results: Group therapy saved 50.9% of clinician costs for MDMA-PTSD and 34.7% for psilocybin-MDD, or $3,467 and $981 per patient, respectively. To treat all eligible PTSD and MDD patients in the U.S. in 10 years with group therapy, 6,711 fewer full-time equivalent (FTE) clinicians for MDMA-PTSD and 1,159 fewer for FTE clinicians for psilocybin-MDD would be needed, saving up to $10.3 billion and $2.0 billion respectively, discounted at 3% annually. Conclusion: Adopting group therapy protocols where feasible would significantly reduce the cost of psychedelic-assisted therapies. By enhancing the number of patients served per clinician, group therapy could also ameliorate the anticipated shortage of appropriately trained clinicians, thereby accelerating access to these promising new therapies.
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RATIONALE & OBJECTIVES: ± 3,4-Methylenedioxymethamphetamine (MDMA) and psilocybin are currently moving through the US Food and Drug Administration's phased drug development process for psychiatric treatment indications: posttraumatic stress disorder and depression, respectively. The current standard of care for these disorders involves treatment with psychiatric medications (e.g., selective serotonin reuptake inhibitors), so it will be important to understand drug-drug interactions between MDMA or psilocybin and psychiatric medications. METHODS: In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we queried the MEDLINE database via PubMed for publications of human studies in English spanning between the first synthesis of psilocybin (1958) and December 2020. We used 163 search terms containing 22 psychiatric medication classes, 135 specific psychiatric medications, and 6 terms describing MDMA or psilocybin. RESULTS: Forty publications were included in our systematic review: 26 reporting outcomes from randomized controlled studies with healthy adults, 3 epidemiologic studies, and 11 case reports. Publications of studies describe interactions between MDMA (N = 24) or psilocybin (N = 5) and medications from several psychiatric drug classes: adrenergic agents, antipsychotics, anxiolytics, mood stabilizers, NMDA antagonists, psychostimulants, and several classes of antidepressants. We focus our results on pharmacodynamic, physiological, and subjective outcomes of drug-drug interactions. CONCLUSIONS: As MDMA and psilocybin continue to move through the FDA drug development process, this systematic review offers a compilation of existing research on psychiatric drug-drug interactions with MDMA or psilocybin.
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Alucinógenos , N-Metil-3,4-metilenodioxianfetamina , Trastornos por Estrés Postraumático , Adulto , Interacciones Farmacológicas , Alucinógenos/farmacología , Alucinógenos/uso terapéutico , Humanos , N-Metil-3,4-metilenodioxianfetamina/farmacología , Psilocibina/efectos adversos , Psicoterapia/métodos , Trastornos por Estrés Postraumático/psicologíaRESUMEN
Introduction: Transgender and gender diverse (TGD) people experience stigma, discrimination, trauma, and post-traumatic stress disorder (PTSD) at higher rates compared to the general population; however, TGD people have been underrepresented in PTSD research. Clinical trials of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy demonstrate promising safety and efficacy for the treatment of PTSD. Issues related to equitable access, power imbalances in the therapeutic relationship, and vulnerable states of consciousness occasioned by MDMA are magnified when working with people affected by structural vulnerabilities and health disparities, and community engagement in research planning and implementation is essential. To inform the inclusion and safety of TGD people in future MDMA-assisted psychotherapy research, the aims of the current study were to: characterize TGD experiences with trauma-related mental health care, assess openness of TGD people to participate in experimental PTSD research, and to gather specific feedback on protocol design for conducting MDMA-assisted psychotherapy with TGD people. Materials and methods: We conducted three virtual focus group discussions (FGDs) with 5-6 participants each (N = 17). Eligible TGD participants had a history of receiving trauma-related mental health care. Each FGD was facilitated by two licensed clinicians who identified as TGD. Qualitative data analysis was conducted via an iterative process of identification of recurrent patterns and themes. Results: We have identified several key issues TGD people face when seeking and engaging in trauma-related mental health care, including barriers to receiving adequate gender-affirming and trauma-informed mental health care and frustration with providers lacking cultural humility. Suggested amendments to MDMA-assisted psychotherapy protocols include: routine collection of trans-inclusive gender identity data, implementing an explicit gender-affirming treatment approach, ensuring a culturally safe setting, and diversifying co-therapy dyads. Discussion: The inclusion of TGD voices in early conversations about emerging experimental PTSD interventions promotes equitable access, in the context of health and healthcare disparities, and helps researchers understand the needs of the community and tailor research to meet those needs. Through an ongoing conversation with the TGD community, we aim to incorporate a gender-affirming approach into existing research protocols and inform future applications of MDMA-assisted psychotherapy in addressing the effects of minority stress and boosting resilience.
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Co-occurring posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) is common and particularly associated with elevation of hyperarousal compared to PTSD alone. Treatment options are limited. Oxytocin regulates physiological stress response. Intranasal oxytocin administration has demonstrated potential in reducing symptoms of both PTSD and AUD. This study addresses a gap in the literature by investigating effects of intranasal oxytocin on startle reactivity, an important potential marker of both PTSD and AUD symptomatology. This is a randomized, double-blind, placebo-controlled, within- and between-participant, crossover, dose-ranging study examining the effects of a single administration of oxytocin 20 IU versus 40 IU versus placebo on psychophysiological responses to a common laboratory fear-potentiated acoustic startle paradigm in participants with PTSD-AUD (nâ¯=â¯47) and controls (nâ¯=â¯37) under three different levels of threat. Contrary to our hypothesis, for the PTSD-AUD group, oxytocin 20 IU had no effect on startle reactivity, while oxytocin 40 IU increased measures of startle reactivity. Additionally, for PTSD-AUD only, ambiguous versus low threat was associated with an elevated skin conductance response. For controls only, oxytocin 20 IU versus placebo was associated with reduced startle reactivity.
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Alcoholismo , Trastornos por Estrés Postraumático , Acústica , Alcoholismo/complicaciones , Alcoholismo/diagnóstico , Alcoholismo/tratamiento farmacológico , Miedo , Humanos , Oxitocina/farmacología , Oxitocina/uso terapéutico , Reflejo de Sobresalto , Trastornos por Estrés Postraumático/complicaciones , Trastornos por Estrés Postraumático/diagnóstico , Trastornos por Estrés Postraumático/tratamiento farmacológicoRESUMEN
Attachment insecurity is determined early in life, is a risk factor for psychopathology, and can be measured on two separate continuous dimensions: attachment anxiety and attachment avoidance. Therapeutic changes toward more secure attachment correlate with reduction in psychiatric symptoms. Psilocybin-assisted psychotherapy has demonstrated promise in the treatment of psychopathology, such as treatment-resistant depression and substance use disorders. We hypothesized that psilocybin-assisted psychotherapy would reduce attachment anxiety and attachment avoidance, thus increasing attachment security. We also hypothesized that baseline measures of attachment insecurity, which can reflect a diminished capacity for trust and exploration, would inform the quality of the psilocybin session. Participants were male long-term AIDS survivors with moderate-severe demoralization (n = 18). Using the Experiences in Close Relationships scale, we measured attachment insecurity at baseline as well as immediately, and 3 months, after completion of a brief group therapy course, which included a single midtreatment open-label psilocybin session conducted individually. Clinically important aspects of the psilocybin session were assessed using the revised Mystical Experience Questionnaire and the Challenging Experience Questionnaire the day following psilocybin administration. Self-reported ratings of attachment anxiety decreased significantly from baseline to 3-months post-intervention, t(16) = -2.2; p = 0.045; d rm = 0.45; 95% CI 0.01, 0.87. Attachment avoidance did not change significantly. Baseline attachment anxiety was strongly correlated with psilocybin-occasioned mystical-type experiences, r(15) = 0.53, p = 0.029, and baseline attachment avoidance was strongly correlated with psilocybin-related challenging experiences, r(16) = 0.62, p = 0.006. These findings have important implications for the general treatment of psychopathology as well as optimizing psilocybin-assisted psychotherapy as a broadly applicable treatment modality.
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The increasing prevalence of illicit stimulant use among those in opioid treatment programs poses a significant risk to public health, stimulant users have the lowest rate of retention and poorest outcomes among those in addiction treatment, and current treatment options are limited. Oxytocin administration has shown promise in reducing addiction-related behavior and enhancing salience to social cues. We conducted a randomized, double-blind, placebo-controlled clinical trial of intranasal oxytocin administered twice daily for 6 weeks to male Veterans with stimulant use disorder who were also receiving opioid agonist therapy and counseling (n = 42). There was no significant effect of oxytocin on stimulant use, stimulant craving, or therapeutic alliance over 6 weeks. However, participants receiving oxytocin (vs. placebo) attended significantly more daily opioid agonist therapy dispensing visits. This replicated previous work suggesting that oxytocin may enhance treatment engagement among individuals with stimulant and opioid use disorders, which would address a significant barrier to effective care.
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Patients and psychotherapists often exhibit behavioral, psychological, and physiological similarity. Here, we test whether oxytocin-a neuropeptide that can enhance expressivity and social perception-influences time-lagged "linkage" of autonomic nervous system responses among participants and facilitators during group therapy. Physiological linkage estimates (n = 949) were created from ten cohorts, each with two facilitators (n = 5) and four to six participants (n = 48), over six weekly sessions of group therapy for methamphetamine use disorder. All participants of a cohort received oxytocin or placebo intranasally in a randomized double-blind procedure before each session. Cardiac interbeat intervals (IBI) were measured continuously during sessions to estimate physiological linkage, operationalized as one cohort-mate's IBI reactivity during one minute predicting another cohort-mate's IBI reactivity during the following minute. In oxytocin cohorts, participants and facilitators experienced significant physiological linkage to their cohort-mates (i.e., their physiological responses were predicted by the prior responses of their cohort-mates) and significantly more linkage than people in placebo cohorts. Both effects occurred during the first and second sessions but not later sessions. Results suggest that oxytocin may enhance psychosocial processes often associated with linkage-such as social engagement-in groups and highlight oxytocin's potential to improve group cohesion during group therapy.Clinical Trials Registration: NCT02881177, First published on 26/08/2016.
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Trastornos Relacionados con Anfetaminas/terapia , Estimulantes del Sistema Nervioso Central/efectos adversos , Metanfetamina/efectos adversos , Oxitocina/administración & dosificación , Psicoterapia de Grupo , Adolescente , Adulto , Anciano , Trastornos Relacionados con Anfetaminas/diagnóstico , Trastornos Relacionados con Anfetaminas/etiología , Terapia Combinada , Manejo de la Enfermedad , Humanos , Masculino , Persona de Mediana Edad , Psicoterapia de Grupo/métodos , Minorías Sexuales y de Género , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: Mimicking movements of others makes both the imitating and imitated partners feel closer. Oxytocin may increase focus on others and has been shown to increase automatic imitation in healthy controls (HC). However, this has not been replicated, and oxytocin's effects on automatic imitation have not been demonstrated in clinical populations. This study attempts to replicate effects on HC and examine effects on people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD). METHODS: Fifty-four males with PTSD-AUD and 43 male HC received three intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU) in a randomized order, across three separate testing days, as part of a double-blind, crossover parent study. At 135 min post-administration, each performed the imitation-inhibition task, which quantifies automatic imitation as the congruency effect (CE). After exclusions, the final analyzed data set included 49 participants with PTSD-AUD and 38 HC. RESULTS: In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase. In PTSD-AUD, oxytocin did not significantly increase CE. Post-hoc analysis showed the PTSD-AUD group had higher CE than HC on placebo visits. DISCUSSION: Our data suggest PTSD-AUD is associated with higher automatic imitation than HC in the absence of oxytocin administration. We successfully replicated findings that oxytocin increases automatic imitation in HC. This demonstrates an unconscious motor effect induced by oxytocin, likely relevant to more complex forms of imitative movements, which have the potential to improve social connection. We did not find a significant effect of oxytocin on automatic imitation in PTSD-AUD. Future research should examine imitation in both sexes, at peak oxytocin levels, and on increasingly complex forms of imitation.
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Alcoholismo/tratamiento farmacológico , Conducta Imitativa/efectos de los fármacos , Oxitocina/uso terapéutico , Trastornos por Estrés Postraumático/tratamiento farmacológico , Administración Intranasal/métodos , Adulto , Comorbilidad , Estudios Cruzados , Método Doble Ciego , Humanos , Inhibición Psicológica , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Methamphetamine (METH) use is a public health crisis that disproportionately affects men who have sex with men (MSM). There are currently no FDA-approved pharmacological interventions to treat methamphetamine use disorder (MUD). MUD is associated with social impairments and extremely high treatment attrition rates. Administration of oxytocin, a neuropeptide involved in social attachment, may be a novel approach to addressing these issues. Moreover, oxytocin administration has shown promise for reducing METH-related addictive behavior in animal models, but has not yet been investigated in clinical trials for MUD. Last, oxytocin is known to modulate stress responsivity via regulation of the autonomic nervous system, which is dysregulated in METH users. We hypothesize that oxytocin, in combination with group psychotherapy, will increase treatment engagement, reduce addiction behavior, and mitigate stress hyperreactivity. METHODS: This is a randomized, double blind trial of oxytocin 40-IU (n = 24) or placebo (n = 24) administered intranasally prior to each of six weekly motivational interviewing group therapy (MIGT) sessions for MUD in MSM. PRIMARY OUTCOME: (a) session attendance. SECONDARY OUTCOMES: (b) group cohesion, (c) anxiety, (d) METH craving, (e) METH use, and (f) in-session cardiac physiology. RESULTS: Participants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014. There was a small effect of oxytocin on group cohension, but not anxiety or craving. METH use did not change over the six-week MIGT course in either treatment arm. Participants receiving oxytocin had lower average heart rates during MIGT sessions and higher heart rate variability. There were positive main effects of MIGT over Time regardless of study drug. CONCLUSIONS: This evidence, and the lack of any serious adverse events, suggests that oxytocin may safely increase treatment attendance. One possible mechanism by which it may do so is its modulation of the autonomic nervous system. Further investigation is warranted.
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Estimulantes del Sistema Nervioso Central , Metanfetamina , Psicoterapia de Grupo , Minorías Sexuales y de Género , Comportamiento de Búsqueda de Drogas , Homosexualidad Masculina , Humanos , Masculino , Oxitocina , AutoadministraciónRESUMEN
INTRODUCTION: Social isolation and alcohol and substance use disorders (ASUD) have been identified as global health risks. Social support is protective against developing ASUD and is associated with beneficial addiction treatment outcomes. Socially stigmatized populations are at higher risk of both social isolation and ASUD, and the link between social support and substance use in these populations has been less researched than in general substance-using populations. We hypothesized that perceived social support, as measured by the Social Provisions Scale (SPS), would have an inverse relationship with frequency of substance use, from subsections of the Addiction Severity Index (ASI) that estimate use over the past 30â¯days and over an individual's lifetime. METHODS: Using a cross-sectional design, we conducted secondary correlational analyses with pre-existing data to test our hypothesis in two separate samples made up of socially marginalized populations entering ASUD treatment programs. Sample 1: substance-using male prison inmates (nâ¯=â¯72, average ageâ¯=â¯30.79) and Sample 2: primary methamphetamine-using men who have sex with men (nâ¯=â¯86, average ageâ¯=â¯43.41). RESULTS: Significant negative correlations were found between SPS and lifetime use of alcohol, tobacco, and cannabis (r s â¯-â¯0.27, -0.39, -0.26; p-values 0.04, 0.001, 0.04, respectively) in Sample 1 and 30-day use of methamphetamine (r s â¯-â¯0.28; p-value 0.008) in Sample 2. DISCUSSION: Differences in results between the samples (lifetime vs 30-day use) may reflect psychosocial and contextual differences impacting perceived social support. Our findings provide support for an important link between perceived social support and frequency of substance use in socially stigmatized populations.
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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.
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Trastornos Relacionados con Anfetaminas/terapia , Estimulantes del Sistema Nervioso Central , Homosexualidad Masculina/psicología , Metanfetamina , Entrevista Motivacional/métodos , Oxitocina/administración & dosificación , Psicoterapia de Grupo/métodos , Minorías Sexuales y de Género/psicología , Administración Intranasal , Adolescente , Adulto , Anciano , Trastornos Relacionados con Anfetaminas/diagnóstico , Trastornos Relacionados con Anfetaminas/psicología , Terapia Combinada , Método Doble Ciego , Humanos , Masculino , Persona de Mediana Edad , Oxitocina/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , San Francisco , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
RATIONALE: There has been an explosion of research on the potential benefits of the social neuropeptide oxytocin for a number of mental disorders including substance use disorders. Recent evidence suggests that intranasal oxytocin has both direct anti-addiction effects and pro-social effects that may facilitate engagement in psychosocial treatment for substance use disorders. OBJECTIVES: We aimed to assess the tolerability of intranasal oxytocin and its effects on heroin craving, implicit association with heroin and social perceptual ability in opioid-dependent patients receiving opioid replacement therapy (ORT) and healthy control participants. METHODS: We performed a randomized, double-blind, placebo-controlled, within- and between-subjects, crossover, proof-of-concept trial to examine the effects of oxytocin (40 international units) on a cue-induced craving task (ORT patients only), an Implicit Association Task (IAT), and two social perception tasks: the Reading the Mind in the Eyes Task (RMET) and The Awareness of Social Inference Test (TASIT). RESULTS: Oxytocin was well tolerated by patients receiving ORT but had no significant effects on craving or IAT scores. There was a significant reduction in RMET performance after oxytocin administration versus placebo in the patient group only, and a significant reduction in TASIT performance after oxytocin in both the patient and healthy control groups. CONCLUSIONS: A single dose of intranasal oxytocin is well tolerated by patients receiving ORT, paving the way for future investigations. Despite no significant improvement in craving or IAT scores after a single dose of oxytocin and some evidence that social perception was worsened, further investigation is required to determine the role oxytocin may play in the treatment of opioid use disorder. CLINICAL TRIAL REGISTRATION: Methadone Oxytocin Option. ClinicalTrials.gov identifier: NCT01728909.