No registrations found.
ID
Source
Brief title
Health condition
PMD Premenstrual Disorders
PMS Premenstrual syndrome
PMDD Premenstrual dysphoric disorders
Substance related disorders
Sponsors and support
Intervention
Outcome measures
Primary outcome
association between level of PMS signs and symptoms and level of problematic use of psychoactive substances
Secondary outcome
craving for psychoactive substances in relation to PMS sign and symptoms
Background summary
SUMMARY
Rationale: Participants in research on Substance Use Disorders (SUD) is mostly done in men. Limited scientific research is available on women and SUD. A theme that has received little attention is the influence of the menstrual cycle on SUD. In particular, the relationship between a premenstrual syndrome (PMS) and SUD has been given little attention. Premenstrual dysphoric disorder (PMDD) is the severe form of (PMS). Clinical practice shows that women with PMS sometimes use substance to alleviate the symptoms of PMS. Women with PMS-complaints drink more alcohol (12% - 39%) than women in a control group without PMS. Until now it is not clear how many addicted women suffer from PMS and how many women with PMS have SUD.
Objectives: Primary aim: to estimate the prevalence of the co-occurrence of PMS and SUD in women. Secondary aim: exploring craving for psychoactive substances a week before menstruation.
Study design: Explorative observational prospective cross-sectional study.
Study populations: all participants (n=300) patients in Dutch addiction institutes (n=100), outpatient clinics for gynecology (n=100) and primary care practices (n=100).
Intervention: this is a non-intervention study
Main study parameters/endpoints: This study protocol focuses on the co-occurrence of the Premenstrual Syndrome (PMS) and Substance Use Disorders (SUD) assessed with questionnaires.
Nature and extent of the burden and risks associated with participation:
According to the experience of the addiction medicine specialists with this population, no problems are expected with answering the questionnaires. The estimated time for filling out the questionnaires is 30 – 40 minutes.
Ethical clearance: The study has been reviewed by the ethics committee of the Radboud University Nijmegen Medical Centre on the basis of the Dutch Code of conduct for health research, the Dutch Code of conduct for responsible use, the Dutch Personal Data Protection Act and the Medical Treatment Agreement Act. The ethics committee has passed a positive judgment on the study (2018-4349).
Study objective
PMS increases the chance of problematic use of psychoactive substances.
In case of problematic use of psychoactive substances the prevalence of PMS is higher than in case of non problematic use.
Study design
this is a crosssectional study with one measurement
Intervention
This is an non-intervention study
Inclusion criteria
Inclusion criteria :
• Women between the ages of 18 and 45
• The ability to understand and sign written informed consent
Exclusion criteria
Recent history of clinically significant psychiatric illness including any psychotic disorder e.g. schizophrenia, bipolar disorder or severe depression, suicidal ideation, menopause.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7315 |
| NTR-old | NTR7532 |
| Other | Commissie Mensgebonden Onderzoek : 2018-4349 |
Summary results
Qurishi R, Arts-de Jong M, Franzek EJ, Hartman L and De Jong CAJ. Influence of Premenstrual Syndrome on Relapse in Nicotine Abuse a Case Report . Austin J Drug Abuse and Addict. 2015; 2(1): 1005.