Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a pilot study

Conditions

Gambling disorder

Brief summary

Protocol completion rate, defined as the proportion of randomized participants who completed all scheduled visits and procedures, including all PAP sessions/control sessions and follow-up assessments until the end of study participation.

Detailed description

Changes in mean scores (+ standard deviations) or proportions, in each arm, between baseline assessment (V0) and post-treatment assessment: - Personal self-efficacy (General Self-Efficacy Scale: GSES); - Clinical Global Impression-Severity (CGI-S); - self-compassion (Self-Compassion Scale: SCS); - spirituality (WHOQOL-SRPB);- intensity, frequency, and duration of craving episodes and daily journaling., Correlation between the intensity of the psychedelic experience, measured by the MEQ-30 score obtained post-administration, and the mean scores (+ standard deviations) or proportions at baseline of the following variables in the experimental arm: spirituality (WHOQOL-SRPB); self-compassion (SCS); treatment expectations (CEQ at baseline); personal self-efficacy (GSES); average dose of IMP administered during the two sessions; measurement of blind maintenance., Average scores (+ standard deviations) or proportions, in each arm: of HR and BP, assessed during administration sessions; expected acute effects (17-item behavior and mood observation grid), assessed during administration sessions; number, type, severity, and attributability of AEs (excluding expected acute effects), assessed during administration sessions and throughout the study;increased risk of suicide;therapeutic index and clinical improvement., Recruitment feasibility validated if the goal of participants within the planned inclusion period is achieved (CONSORT diagram ; participants continuing treatment to the end in each arm;Assessment of blind maintenance), self-reported acceptability by patients and caregivers: duration, number, and frequency of sessions; reasons for refusal to participate by eligible patients and dropouts

Related papers

No related papers found yet.

Interventions

DRUGPEX010 Psilocybin Capsules (1.0 mg psilocybin)

DRUGPCB2 (Placebo PEX010) capsules

DRUGPEX010 Psilocybin Capsules (25.0 mg psilocybin)

DRUGPEX010 Psilocybin Capsules (5.0 mg psilocybin)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Protocol completion rate, defined as the proportion of randomized participants who completed all scheduled visits and procedures, including all PAP sessions/control sessions and follow-up assessments until the end of study participation.	—

Secondary

Measure	Time frame
Changes in mean scores (+ standard deviations) or proportions, in each arm, between baseline assessment (V0) and post-treatment assessment: - Personal self-efficacy (General Self-Efficacy Scale: GSES); - Clinical Global Impression-Severity (CGI-S); - self-compassion (Self-Compassion Scale: SCS); - spirituality (WHOQOL-SRPB);- intensity, frequency, and duration of craving episodes and daily journaling., Correlation between the intensity of the psychedelic experience, measured by the MEQ-30 score obtained post-administration, and the mean scores (+ standard deviations) or proportions at baseline of the following variables in the experimental arm: spirituality (WHOQOL-SRPB); self-compassion (SCS); treatment expectations (CEQ at baseline); personal self-efficacy (GSES); average dose of IMP administered during the two sessions; measurement of blind maintenance., Average scores (+ standard deviations) or proportions, in each arm: of HR and BP, assessed during administration sessions;	—

Measure

Time frame

Changes in mean scores (+ standard deviations) or proportions, in each arm, between baseline assessment (V0) and post-treatment assessment: - Personal self-efficacy (General Self-Efficacy Scale: GSES); - Clinical Global Impression-Severity (CGI-S); - self-compassion (Self-Compassion Scale: SCS); - spirituality (WHOQOL-SRPB);- intensity, frequency, and duration of craving episodes and daily journaling., Correlation between the intensity of the psychedelic experience, measured by the MEQ-30 score obtained post-administration, and the mean scores (+ standard deviations) or proportions at baseline of the following variables in the experimental arm: spirituality (WHOQOL-SRPB); self-compassion (SCS); treatment expectations (CEQ at baseline); personal self-efficacy (GSES); average dose of IMP administered during the two sessions; measurement of blind maintenance., Average scores (+ standard deviations) or proportions, in each arm: of HR and BP, assessed during administration sessions;

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Countries

France

Outcome results

None listed