Cocaine Dependence
Conditions
Brief summary
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.
Interventions
BEHAVIORALMontreal Imaging Stress Task
Math task developed to induce a stress response in a laboratory setting
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
GGeneral Inclusion /
Exclusion criteria
Inclusion Criteria 1. Pre-menopausal. Individuals who are no longer menstruating regularly will not be included as we are examining ovarian hormone status on stress reactivity. 2. Right-handed 3. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 4. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the CTRC admission. Participants must have a negative breathalyzer, urine drug screen. 5. Subjects must consent to outpatient admission to the CTRC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood oxygen level dependent (BOLD)signal activation in limbic brain regions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress response on 0-10 Likert scale | 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. |
| Subjective craving on 0-10 Likert scale | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Salivary cortisol levels | 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. |
Countries
United States
Outcome results
None listed