Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218257
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2005-09-16
Brief Title:
Progesterone for the Treatment of Cocaine Dependence - 1
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Interactions Between Progesterone and Cocaine in Women
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Past research has demonstrated that cocaine dependent women experience less severe responses to cocaine during the luteal phase of the menstrual cycle when estrogen and progesterone concentrations are high The purpose of this study is to determine whether administered progesterone reduces subjective and physiological responses to cocaine in cocaine dependent individuals
Detailed Description:
Changes in ovarian hormones across the menstrual cycle impact responses to cocaine in women Studies have shown that cocaines effects are dampened during the luteal phase of the menstrual cycle when estrogen and progesterone concentrations are high relative to the other phases of the cycle when concentrations of these hormones are relatively low The purpose of this study is to determine whether progesterone reduces subjective and physiological responses to cocaine in cocaine dependent individuals In addition this study will help to advance the possibility of hormonal progesterone and pharmacologically-related drugs as potential treatment components for cocaine abuse
Participants will undergo two 4-day inpatient periods totaling 8 days of treatment For women the inpatient periods will occur during two consecutive menstrual cycles for men these will occur during two consecutive months On Day 1 participants will receive a first dose of either progesterone or placebo On Day 2 participants will receive a second and third dose of study medication Participants will also participate in an adaptation session which will familiarize the participant with the smoking equipment that will be used the following day On Day 3 participants will receive a fourth dose of medication 2 hours prior to a smoking lab session Prior to beginning the smoking lab session participants will be asked to rate their current cocaine craving anxiety level appetite and premenstrual symptoms Participants will then be given a sample of the cocaine dose for the given day During the smoking lab session participants will be asked additional cocaine craving questions at pre-determined intervals and will be given the option to trade in previously earned tokens for either money or a dose of cocaine Following completion of the smoking lab session participants will receive their fifth dose of medication
Participants will undergo two 4-day inpatient periods totaling 8 days of treatment For women the inpatient periods will occur during two consecutive menstrual cycles for men these will occur during two consecutive months On Day 1 participants will receive a first dose of either progesterone or placebo On Day 2 participants will receive a second and third dose of study medication Participants will also participate in an adaptation session which will familiarize the participant with the smoking equipment that will be used the following day On Day 3 participants will receive a fourth dose of medication 2 hours prior to a smoking lab session Prior to beginning the smoking lab session participants will be asked to rate their current cocaine craving anxiety level appetite and premenstrual symptoms Participants will then be given a sample of the cocaine dose for the given day During the smoking lab session participants will be asked additional cocaine craving questions at pre-determined intervals and will be given the option to trade in previously earned tokens for either money or a dose of cocaine Following completion of the smoking lab session participants will receive their fifth dose of medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | OTHER | NIDA | httpsreporternihgovquickSearchR01DA014573 |
| R01DA014573 | NIH | None | None |