The purpose of this study is to examine if the administration of progesterone will attenuate subjective and physiological responses to crack cocaine in female and male crack abusers. The study will help to advance our understanding of hormonal mechanisms in cocaine abuse, as well as to explore the potential utility of progesterone or pharmacologically related drugs as potential components of treatment for cocaine abuse.

Condition	Intervention
Cocaine Abuse Cocaine-Related Disorders	Drug: Progesterone

Further Study Details: 

After being cleared at an outpatient physical by one of the study physcians, subjects will be admitted for a period of four days on two consecutive menstrual cycles, or in men two consecutive months, totalling 8 days. Once admitted to the General Clinical Research Center, subjects will receive their first dose of either progesterone or placebo. The following day they will receive their second dose of study medication and participate in an adaptation session. The purpose of this practice day is to familiarize the subject witht the smoking equiptment. That evening the subject receives their third dose of study medication. The third day the subjects receives their fourth dose of medication two hours prior to their time in the smoking lab. Subjects then complete 500 single digit math problems to earn 5 tokens. These tokens are then used during the actual experimental smoking session. Just prior to beginning the session, subjects are asked a series of questions to rate such things as current cocaine craving, anxiety level, appetite, and premenstrual symptoms. Subjects are then given a sample of what their dose of smoked cocaine dose will be for the day. More cocaine craving question are asked at predetermined intervals for the next 25 minutes. Subjects are then asked to choose an action with their earned token. The token can be kept by the subject to earn $5.00, or be given bck to study staff for a dose of smoked cocaine. This is done for each of the 5 tokens earned. After all 5 choice points are finished the experimental session is completed for the day. That evening the subject receives their 5th dose of study medication. The following day the same protocol is followed. After completion of the experimental session and a discharge physical the subject is discharged from the study. As stated earlier the subject will then return for a second month and complete the same protocol.

Ages Eligible for Study:  18 Years   -   46 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Smoked cocaine of at least 1 gram per week for the 6 months prior to enrollment
• Current history of good health
• Normal electrocardiogram
• Using an adequate form of contraception for the duration of the study, other than hormonal oral contraceptives.
• If female, experiences regular menses

Exclusion Criteria:

• Current problems with major psychiaric illnesses including psychotic mood and anxiety disorders
• Current dependence of alcohol or on drugs other that cocaine or nicotine
• History of major medical illnesses, including liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, thrombophlebitis or other medical conditions, as determined by the study physician
• If female, Irregular menses
• Current use of oral or other types of hormonal contraceptives
• Currently on parole or probation
• Treated for chemical dependency within the 6 months prior to enrollment
• Known allergy to progesterone or peanuts

Please refer to this study by ClinicalTrials.gov identifier  NCT00218257

Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States

Study chairs or principal investigators

Sheila M Specker, M.D.,  Principal Investigator,  University of Minnesota Twin Cities   

Study ID Numbers:  NIDA-14573-1; R01-14573-1
Last Updated:  September 21, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00218257
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27