OPEN Foundation

Menu
Search
Close this search box.

Safety

Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction

September 11, 2014 / Mushrooms / Psilocybin, Mystical experiences, Papers, Psychiatry, Psychology, Psychopharmacology, Psychotherapy, Publications, Safety, Substance Use Disorder / By / , , ,

Abstract

Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow-up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20 mg/70 kg) and high (30 mg/70 kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of six previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction.

Johnson, M. W., Garcia-Romeu, A., Cosimano, M. P., & Griffiths, R. R. (2014). Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction. Journal of Psychopharmacology, 28(11), 983-992. http://dx.doi.org/10.1177/0269881114548296
Link to full article

By its fruits? Mystical and visionary states of consciousness occasioned by entheogens

August 26, 2014 / Mushrooms / Psilocybin, Mystical experiences, Papers, Personality, Publications, Religious studies, Safety, Spirituality / By /

Abstract

A new era has emerged in research on entheogens largely due to clinical trials conducted at Johns Hopkins University and similar studies sponsored by the Council for Spiritual Practices. In these notes and queries, I reflect on implications of these developments for psychological studies of religion and on what this research may mean for Christian churches in the United States. I conclude that the aims and methods of this research fit well within Jamesian efforts of contemporary psychology of religion to assess religious practices by their fruits for life. Furthermore, some communitarian religious concerns that religious experiences occasioned by entheogens pose risks to the integrity of religious community are shown to be largely unfounded. However, it is suggested that certain risks for religious life posed by all investigations/interventions by knowledge experts—in particular, the colonization of the religious life world and the commodification of its practices—also attend these developments for Christian churches. Additionally, risks of individual harm in the use of entheogens appear to be significant and, therefore, warrant earnest ethical study.

Hummel, L. (2014). By its fruits? Mystical and visionary states of consciousness occasioned by entheogens. Zygon: Journal of Religion and Science, 49(3), 685-695. http://dx.doi.org/10.1111/zygo.12112
Link to full text

Hallucinogen persisting perception disorder and the serotonergic system: A comprehensive review including new MDMA-related clinical cases

June 7, 2014 / HPPD, Neuroscience, Papers, Psychiatry, Psychology, Psychopharmacology, Publications, Safety / By / , , ,

Abstract

Hallucinogen persisting perception disorder (HPPD) is a drug-induced condition associated with inaccurate visual representations. Since the underlying mechanism(s) are largely unknown, this review aims to uncover aspects underlying its etiology. Available evidence on HPPD and drug-related altered visual processing was reviewed and the majority of HPPD cases were attributed to drugs with agonistic effects on serotonergic 5-HT2A receptors. Moreover, we present 31 new HPPD cases that link HPPD to the use of ecstasy (MDMA), which is known to reverse serotonin reuptake and acts as agonist on 5-HT2A receptors. The available evidence suggests that HPPD symptoms may be a result from a misbalance of inhibitory-excitatory activity in low-level visual processing and GABA-releasing inhibitory interneurons may be involved. However, high co-morbidities with anxiety, attention problems and derealization symptoms add complexity to the etiology of HPPD. Also, other perceptual disorders that show similarity to HPPD cannot be ruled out in presentations to clinical treatment. Taken together, evidence is still sparse, though low-level visual processing may play an important role. A novel finding of this review study, evidenced by our new cases, is that ecstasy (MDMA) use may also induce symptoms of HPPD.

Litjens, R. P., Brunt, T. M., Alderliefste, G. J., & Westerink, R. H. (2014). Hallucinogen persisting perception disorder and the serotonergic system: A comprehensive review including new MDMA-related clinical cases. European Neuropsychopharmacology, 24(8), 1309-1323. https://dx.doi.org/10.1016/j.euroneuro.2014.05.008

Link to full text

Hallucinogens causing seizures? A case report of the synthetic amphetamine 2,5-dimethoxy-4-chloroamphetamine

April 1, 2014 / Medicine, Other substances, Papers, Publications, Safety / By / , , , ,

Abstract

Although traditional hallucinogenic drugs such as marijuana and lysergic acid diethylamide (LSD) are not typically associated with seizures, newer synthetic hallucinogenic drugs can provoke seizures. Here, we report the unexpected consequences of taking a street-bought hallucinogenic drug thought to be LSD. Our patient presented with hallucinations and agitation progressing to status epilepticus with a urine toxicology screen positive only for cannabinoids and opioids. Using liquid chromatography high-resolution mass spectrometry, an additional drug was found: an amphetamine-derived phenylethylamine called 2,5-dimethoxy-4-chloroamphetamine. We bring this to the attention of the neurologic community as there are a growing number of hallucinogenic street drugs that are negative on standard urine toxicology and cause effects that are unexpected for both the patient and the neurologist, including seizures.

Burish, M. J., Thoren, K. L., Madou, M., Toossi, S., & Shah, M. (2014). Hallucinogens Causing Seizures? A Case Report of the Synthetic Amphetamine 2, 5-Dimethoxy-4-Chloroamphetamine. The Neurohospitalist, 5(1), 32-34. https://dx.doi.org/10.1177/1941874414528939
Link to full text

Therapeutic Effects of Ritual Ayahuasca Use in the Treatment of Substance Dependence—Qualitative Results

March 11, 2014 / Ayahuasca, Ethnobotany, Neuroscience, Papers, Phenomenology, Psychology, Psychotherapy, Publications, Safety, Spirituality, Substance Use Disorder, Toxicology / By / ,

Abstract

This qualitative empirical study explores the ritual use of ayahuasca in the treatment of addictions. Ayahuasca is an Amazonian psychedelic plant compound created from an admixture of the vine Banisteriopsis caapi and the bush Psychotria viridis. The study included interviews with 13 therapists who apply ayahuasca professionally in the treatment of addictions (four indigenous healers and nine Western mental health professionals with university degrees), two expert researchers, and 14 individuals who had undergone ayahuasca-assisted therapy for addictions in diverse contexts in South America. The study provides empirically based hypotheses on therapeutic mechanisms of ayahuasca in substance dependence treatment. Findings indicate that ayahuasca can serve as a valuable therapeutic tool that, in carefully structured settings, can catalyze neurobiological and psychological processes that support recovery from substance dependencies and the prevention of relapse. Treatment outcomes, however, can be influenced by a number of variables that are explained in this study. In addition, issues related to ritual transfer and strategies for minimizing undesired side-effects are discussed.

Loizaga-Velder, A., & Verres, R. (2014). Therapeutic Effects of Ritual Ayahuasca Use in the Treatment of Substance Dependence—Qualitative Results. Journal of Psychoactive Drugs, 46(1), 63–72. http://dx.doi.org/10.1080/02791072.2013.873157
Link to full text

MDMA and the “Ecstasy Paradigm”

March 11, 2014 / MDMA, Neuroscience, Papers, Psychiatry, Psychology, Psychopharmacology, Publications, Safety, Sociology, Toxicology / By /

Abstract

For nearly 30 years, there has been a steady flow of research papers highlighting the dangers of MDMA and the implications for ecstasy users. After such a long time, it would be reasonable to expect that these dangers would be obvious due to the large number of ecstasy users. The available evidence does not indicate that there are millions of ecstasy users experiencing any problems linked to their ecstasy use. The “precautionary principle” suggests that, in the absence of knowing for certain, “experts” should argue that MDMA be avoided. However, this may have been taken too far, as the dire warnings do not seem to be reducing with the lack of epidemiological evidence of clinically relevant problems. The “ecstasy paradigm” is one way of articulating this situation, in that the needs of research funders and publication bias lead to a specific set of subcultural norms around what information is acceptable in the public domain. By digging a little deeper, it is easy to find problems with the evidence base that informs the public debate around MDMA. The key question is whether it is acceptable to maintain this status quo given the therapeutic potential of MDMA.

Cole, J. C. (2014). MDMA and the “Ecstasy Paradigm”. Journal of Psychoactive Drugs, 46(1), 44–56. http://dx.doi.org/10.1080/02791072.2014.878148
Link to full text

The Potential Dangers of Using MDMA for Psychotherapy

March 11, 2014 / Anxiety disorders / PTSD, MDMA, Neuroscience, Papers, Psychiatry, Psychology, Psychopharmacology, Psychotherapy, Publications, Safety, Toxicology / By /

Abstract

MDMA has properties that may make it attractive for psychotherapy, although many of its effects are potentially problematic. These contrasting effects will be critically reviewed in order to assess whether MDMA could be safe for clinical usage. Early studies from the 1980s noted that MDMA was an entactogen, engendering feelings of love and warmth. However, negative experiences can also occur with MDMA since it is not selective in the thoughts or emotions it releases. This unpredictability in the psychological material released is similar to another serotonergic drug, LSD. Acute MDMA has powerful neurohormonal effects, increasing cortisol, oxytocin, testosterone, and other hormone levels. The release of oxytocin may facilitate psychotherapy, whereas cortisol may increase stress and be counterproductive. MDMA administration is followed by a period of neurochemical recovery, when low serotonin levels are often accompanied by lethargy and depression. Regular usage can also lead to serotonergic neurotoxicity, memory problems, and other psychobiological problems. Proponents of MDMA-assisted therapy state that it should only be used for reactive disorders (such as PTSD) since it can exacerbate distress in those with a prior psychiatric history. Overall, many issues need to be considered when debating the relative benefits and dangers of using MDMA for psychotherapy.

Parrott, A. C. (2014). The Potential Dangers of Using MDMA for Psychotherapy. Journal of Psychoactive Drugs, 46(1) , 37–43. http://dx.doi.org/10.1080/02791072.2014.873690
Link to full text

Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases

March 3, 2014 / Anxiety disorders / PTSD, LSD, Mystical experiences, Papers, Psychiatry, Psychology, Psychotherapy, Publications, Safety, Spirituality / By / , , , , , ,

Abstract

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 mcg of LSD (n=8) or 20 mcg of LSD with an open-label crossover to 200 mcg 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.

Gasser, P., Holstein, D., Michel, Y., Doblin, R., Yazar-Klosinski, B., Passie, T., & Brenneisen, R. (2014). Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases. The Journal of Nervous and Mental Disease, 202, 1-8. http://dx.doi.org/10.1097/NMD.0000000000000113
Link to full text

IJTS Special Topic Section: Ketamine ● Ketamine (IM) Assisted Psychotherapy (KAP): A Model for Informed Consent

January 1, 2014 / Ketamine, Medicine, Other subjects, Papers, Psychiatry, Psychopharmacology, Publications, Safety / By /

Abstract

Informed consent is important for every medical intervention, and the unique nature of ketamine assisted psychotherapy (KAP) calls for a particularly thoughtful and detailed informed consent document. The following is an informed consent form developed for the author’s use in his own private practice. No representations are made concerning its adequacy or appropriateness for use by other practitioners, or in any other contexts; author, editors, and publisher disclaim liability for any use of or reliance on this document. However, as a document created by a psychiatrist with experience in KAP, this form may serve to illustrate the range of issues that an informed consent document might address.

Wolfson, P. E. (2015). Ketamine (IM) Assisted Psychotherapy (KAP): A Model for Informed Consent. International Journal of Transpersonal Studies.
Link to full text

IJTS Special Topic Section: Ketamine ● Ethnographic Accounts of Ketamine Explorations in Psychedelic Culture

January 1, 2014 / Consciousness, History, Other disciplines, Papers, Personal development, Psychology, Publications, Safety, Sociology, Spirituality, Substance Use Disorder / By / , ,

Abstract

Off-label use of ketamine as a mind-altering substance did not begin in the laboratory, but in the psychedelic culture that grew out of the 1960s counterculture movement. Whatever the risks and limitations of such experimentation, without them the remarkable therapeutic effects of the drug might well have gone unnoticed, and unresearched. The following personal accounts—both inspiring and cautionary—offer glimpses into the cultural contexts that found ketamine to be much more than a reliable anesthetic.

Ring, K., Metzner, R., & Wolfson, P. E. (2014). Ethnographic Accounts of Ketamine Explorations in Psychedelic Culture. International Journal of Transpersonal Studies, 33(2).
Link to full text