Tieteelliset julkaisut

Tulokset kategoriasta menetelmat hakusanalla satunnaistettu. Takaisin


Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy. (Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L.., 2017)
Julkaisu:Journal of Psychopharmacology
Tiivistelmä: A growing body of research suggests that traumatic events lead to persisting personality change characterized by increased neuroticism. Relevantly, enduring improvements in Post-Traumatic Stress Disorder (PTSD) symptoms have been found in response to 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy.

There is evidence that lasting changes in the personality feature of "openness" occur in response to hallucinogens, and that this may potentially act as a therapeutic mechanism of change. The present study investigated whether heightened Openness and decreased Neuroticism served as a mechanism of change within a randomized trial of MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD. The Clinician-Administered PTSD Scale (CAPS) Global Scores and NEO PI-R Personality Inventory (NEO) Openness and Neuroticism Scales served as outcome measures.

Results indicated that changes in Openness but not Neuroticism played a moderating role in the relationship between reduced PTSD symptoms and MDMA treatment. Following MDMA-assisted psychotherapy, increased Openness and decreased Neuroticism when comparing baseline personality traits with long-term follow-up traits also were found.

These preliminary findings suggest that the effect of MDMA-assisted psychotherapy extends beyond specific PTSD symptomatology and fundamentally alters personality structure, resulting in long-term persisting personality change. Results are discussed in terms of possible mechanisms of psychotherapeutic change.
Yhdiste:MDMA
Aihe:Yleiset vaikutukset, stressihäiriö
Menetelmät:Kaksoissokkoutettu, lumekontrolloitu, satunnaistettu, haastattelu, seuranta
Otoskoko:20
Muuta:Tutkimus on jatkoa artikkelille Mithoefer ym. (2011).
Tagit:
DOI:10.1177/0269881117711712
URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5544120/


Treating posttraumatic stress disorder with MDMA-assisted psychotherapy: A preliminary meta-analysis and comparison to prolonged exposure therapy. (Amoroso T, Workman M, 2016)
Julkaisu:Journal of Psychopharmacology
Tiivistelmä: Since the wars in Iraq and Afghanistan, posttraumatic stress disorder (PTSD) has become a major area of research and development. The most widely accepted treatment for PTSD is prolonged exposure (PE) therapy, but for many patients it is intolerable or ineffective. ±3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy (MDMA-AP) has recently re-emerged as a new treatment option, with two clinical trials having been published and both producing promising results. However, these results have yet to be compared to existing treatments.

The present paper seeks to bridge this gap in the literature. Often the statistical significance of clinical trials is overemphasized, while the magnitude of the treatment effects is overlooked. The current meta-analysis aims to provide a comparison of the cumulative effect size of the MDMA-AP studies with those of PE. Effect sizes were calculated for primary and secondary outcome measures in the MDMA-AP clinical trials and compared to those of a meta-analysis including several PE clinical trials.

It was found that MDMA-AP had larger effect sizes in both clinician-observed outcomes than PE did (Hedges' g=1.17 vs. g=1.08, respectively) and patient self-report outcomes (Hedges' g=0.87 vs. g=0.77, respectively). The dropout rates of PE and MDMA-AP were also compared, revealing that MDMA-AP had a considerably lower percentage of patients dropping out than PE did. These results suggest that MDMA-AP offers a promising treatment for PTSD.
Yhdiste:MDMA
Aihe:Stressihäiriö, haitta-arvio
Menetelmät:Meta-analyysi, kaksoissokkoutettu, satunnaistettu, lumekontrolloitu
Otoskoko:0
Muuta:
Tagit:
DOI:10.1177/0269881116642542
URL: http://journals.sagepub.com/doi/abs/10.1177/0269881116642542


Acute Effects of Lysergic Acid Diethylamide in Healthy Subjects. (Schmid Y, Enzler F, Gasser P, Grouzmann E, Preller KH, Volle.., 2015)
Julkaisu:Biological Psychiatry
Tiivistelmä: BACKGROUND:
After no research in humans for >40 years, there is renewed interest in using lysergic acid diethylamide (LSD) in clinical psychiatric research and practice. There are no modern studies on the subjective and autonomic effects of LSD, and its endocrine effects are unknown. In animals, LSD disrupts prepulse inhibition (PPI) of the acoustic startle response, and patients with schizophrenia exhibit similar impairments in PPI. However, no data are available on the effects of LSD on PPI in humans.

METHODS:
In a double-blind, randomized, placebo-controlled, crossover study, LSD (200 μg) and placebo were administered to 16 healthy subjects (8 women, 8 men). Outcome measures included psychometric scales; investigator ratings; PPI of the acoustic startle response; and autonomic, endocrine, and adverse effects.

RESULTS:
Administration of LSD to healthy subjects produced pronounced alterations in waking consciousness that lasted 12 hours. The predominant effects induced by LSD included visual hallucinations, audiovisual synesthesia, and positively experienced derealization and depersonalization phenomena. Subjective well-being, happiness, closeness to others, openness, and trust were increased by LSD. Compared with placebo, LSD decreased PPI. LSD significantly increased blood pressure, heart rate, body temperature, pupil size, plasma cortisol, prolactin, oxytocin, and epinephrine. Adverse effects produced by LSD completely subsided within 72 hours. No severe acute adverse effects were observed.

CONCLUSIONS:
In addition to marked hallucinogenic effects, LSD exerts methylenedioxymethamphetamine-like empathogenic mood effects that may be useful in psychotherapy. LSD altered sensorimotor gating in a human model of psychosis, supporting the use of LSD in translational psychiatric research. In a controlled clinical setting, LSD can be used safely, but it produces significant sympathomimetic stimulation.
Yhdiste:LSD
Aihe:haitta-arvio, yleiset vaikutukset
Menetelmät:kaksoissokkoutettu, satunnaistettu, lumekontrolloitu, vaihtovuoroinen
Otoskoko:16
Muuta:
Tagit: LSD
DOI:10.1016/j.biopsych.2014.11.015
URL: https://www.biologicalpsychiatryjournal.com/article/S0006-3223(14...


Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases. (Gasser P, Holstein D, Michel Y, Doblin R, Yazar-Klosinski B,.., 2014)
Julkaisu:The Journal of Nervous and Mental disease
Tiivistelmä: A double-blind, randomized, active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases.

Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart. The participants received either 200 μg of LSD (n = 8) or 20 μg of LSD with an open-label crossover to 200 μg of LSD after the initial blinded treatment was unmasked (n = 4).

At the 2-month follow-up, positive trends were found via the State-Trait Anxiety Inventory (STAI) in reductions in trait anxiety (p = 0.033) with an effect size of 1.1, and state anxiety was significantly reduced (p = 0.021) with an effect size of 1.2, with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events. STAI reductions were sustained for 12 months.

These results indicate that when administered safely in a methodologically rigorous medically supervised psychotherapeutic setting, LSD can reduce anxiety, suggesting that larger controlled studies are warranted.
Yhdiste:LSD
Aihe:kuolemaan liittyvä ahdistus
Menetelmät:kaksoissokkoutettu, satunnaistettu, lumekontrolloitu, seuranta
Otoskoko:12
Muuta:
Tagit: LSD, pilotti
DOI:10.1097/NMD.0000000000000113
URL: https://journals.lww.com/jonmd/fulltext/2014/07000/Safety_and_Eff...


A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)- assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). (Oehen P, Traber R, Widmer V, Schnyder U, 2013)
Julkaisu:Journal of Psychopharmacology
Tiivistelmä: Psychiatrists and psychotherapists in the US (1970s to 1985) and Switzerland (1988–1993) used MDMA legally as a prescription drug, to enhance the effectiveness of psychotherapy. Early reports suggest that it is useful in treating trauma-related disorders. Recently, the first completed pilot study of MDMA-assisted psychotherapy for PTSD yielded encouraging results.

Designed to test the safety and efficacy of MDMA-assisted psychotherapy in patients with treatment-resistant PTSD; our randomized, double-blind, active-placebo controlled trial enrolled 12 patients for treatment with either low-dose (25 mg, plus 12.5 mg supplemental dose) or full-dose MDMA (125 mg, plus 62.5 mg supplemental dose). MDMA was administered during three experimental sessions, interspersed with weekly non-drug-based psychotherapy sessions. Outcome measures used were the Clinician-Administered PTSD Scale (CAPS) and the Posttraumatic Diagnostic Scale (PDS). Patients were assessed at baseline, three weeks after the second and third MDMA session (end of treatment), and at the 2-month and 1-year follow-ups.

We found that MDMA-assisted psychotherapy can be safely administered in a clinical setting. No drug-related serious adverse events occurred. We did not see statistically significant reductions in CAPS scores (p = 0.066), although there was clinically and statistically significant self-reported (PDS) improvement (p = 0.014). CAPS scores improved further at the 1-year follow-up. In addition, three MDMA sessions were more effective than two (p = 0.016).
Yhdiste:MDMA
Aihe:stressihäiriö
Menetelmät:Kaksoissokkoutettu, lumekontrolloitu, satunnaistettu, seuranta
Otoskoko:12
Muuta:
Tagit: MDMA, PTSD
DOI:10.1177/0269881112464827
URL: http://journals.sagepub.com/doi/abs/10.1177/0269881112464827


The safety and efficacy of 3,4-methylenedioxymethamphetamine- assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study (Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Doblin R, 2011)
Julkaisu:Journal of Psychopharmacology
Tiivistelmä: Case reports indicate that psychiatrists administered 3,4-methylenedioxymethamphetamine (MDMA) as a catalyst to psychotherapy before recreational use of MDMA as ‘Ecstasy’ resulted in its criminalization in 1985.

Over two decades later, this study is the first completed clinical trial evaluating MDMA as a therapeutic adjunct. Twenty patients with chronic posttraumatic stress disorder, refractory to both psychotherapy and psychopharmacology, were randomly assigned to psychotherapy with concomitant active drug (n = 12) or inactive placebo (n = 8) administered during two 8-h experimental psychotherapy sessions. Both groups received preparatory and follow-up non-drug psychotherapy.

The primary outcome measure was the Clinician-Administered PTSD Scale, administered at baseline, 4 days after each experimental session, and 2 months after the second session. Neurocognitive testing, blood pressure, and temperature monitoring were performed.

After 2-month follow-up, placebo subjects were offered the option to re-enroll in the experimental procedure with open-label MDMA. Decrease in Clinician-Administered PTSD Scale scores from baseline was significantly greater for the group that received MDMA than for the placebo group at all three time points after baseline.

The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases. MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory to other treatments.
Yhdiste:MDMA
Aihe:stressihäiriö
Menetelmät:Kaksoissokkoutettu, lumekontrolloitu, satunnaistettu, seuranta
Otoskoko:20
Muuta:
Tagit: MDMA, PTSD
DOI:10.1177/0269881110378371
URL: http://journals.sagepub.com/doi/full/10.1177/0269881110378371


MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder. (Bouso JC, Doblin R, Farré M, Alcázar MA, Gómez-Jarabo G, 2008)
Julkaisu:Journal of Psychoactive Drugs
Tiivistelmä: The purpose of this study was to investigate the safety of different doses of MDMA-assisted psychotherapy administered in a psychotherapeutic setting to women with chronic PTSD secondary to a sexual assault, and also to obtain preliminary data regarding efficacy. Although this study was originally planned to include 29 subjects, political pressures led to the closing of the study before it could be finished, at which time only six subjects had been treated. Preliminary results from those six subjects are presented here. We found that low doses of MDMA (between 50 and 75 mg) were both psychologically and physiologically safe for all the subjects. Future studies in larger samples and using larger doses are needed in order to further clarify the safety and efficacy of MDMA in the clinical setting in subjects with PTSD.
Yhdiste:MDMA
Aihe:stressihäiriö
Menetelmät:Kaksoissokkoutettu, satunnaistettu, lumekontrolloitum seuranta
Otoskoko:6
Muuta:
Tagit:
DOI:10.1080/02791072.2008.10400637
URL: https://www.ncbi.nlm.nih.gov/pubmed/19004414