Medical University of South Carolina
Charleston, South Carolina, 29425, United States
NCT Number: NCT02098434
The study is investigating the impact of progesterone and estrogen on brain areas that are involved with stress response and drug craving. The study will involve 40 women who will participate in the Montreal Imaging Stress Task (MIST) while undergoing fMRI scanning procedures. Half of the women will complete the procedures during the luteal phase of the menstrual cycle; the other half will complete procedures during the follicular phase. Subjective and physiological measures (cortisol levels) will be used to measure stress and craving response. Hypothesis 1A is that all women will exhibit increased craving, stress response, salivary cortisol and BNST and limbic nuclei activation in response to the MIST task. Hypothesis 1B is that these increased responses will be higher for women in the luteal phase than for women in the follicular phase of the menstrual cycle.
Looking for future studies?
Notify Me18 year–65 year
Female
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
GGeneral Inclusion / Exclusion Criteria Inclusion Criteria
Exclusion criteria
Inclusion criteria
Cocaine-Dependent Women a. Women meeting criteria for cocaine-dependence in the previous three months (current).
Exclusion criteria
Cocaine-Dependent Women
a. Subjects meeting DSM-IV criteria for current dependence (within 2 months) on substances other than cocaine. Nicotine dependence can affect HPA function therefore it would be ideal to exclude subjects with nicotine use. Because of the comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. Alcohol has also been known to affect HPA function, however to enhance recruitment efforts, individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification.
Inclusion criteria
Non-Dependent Healthy Control Women a. As above. Exclusion Criteria Non-Dependent Healthy Control Women
a. Women meeting DSM-IV criteria for past or current substance dependence (other than nicotine).
Math task developed to induce a stress response in a laboratory setting
Other names: MIST
Time frame: Scan visit, before and after MIST (day 1)
Exposure to the MIST task will increase activation in these brain areas as measured by fMRI scanning procedures, and the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.
Time frame: Scan visit, before and after MIST (day 1)
Participants are asked to rate stress on a 10-point Likert scale. It is hypothesized that subjective ratings will increase following the MIST task, and that the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.
Time frame: Scan visit, before and after MIST (day 1)
Participants are asked to rate craving on a 10-point Likert scale. It is hypothesized that craving greater after completion of the MIST than before the MIST task, and that the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.
Time frame: Scan visit, before and after MIST (day 1)
Salivary samples will be collected throughout scanning procedures to determine salivary cortisol levels. It is hypothesized that cortisol levels will increase following the MIST task, and that the increase will be more pronounced for women in the luteal rather than follicular phase of the menstrual cycle.
Medical University of South Carolina
Other
Implication of Ovarian Hormones in the Neural Correlates of Stress Induced Drug Craving
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05857852
Chemically-Induced Disorders, Cocaine Abuse
Charlottesville, Virginia, United States
View Trial DetailsNCT04907357
Chemically-Induced Disorders, Cocaine Abuse
Winston-Salem, North Carolina, United States
View Trial DetailsNCT02111798
Chemically-Induced Disorders, Cocaine Dependence
Baltimore, Maryland, United States
View Trial DetailsNCT04994821
Chemically-Induced Disorders, Cocaine Dependence
New York, United States
View Trial Details