Clinical trial NCT00218257: Progesterone for the Treatment of Cocaine Dependence - 1
Official title: Interactions Between Progesterone and Cocaine in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Abuse
Cocaine-Related Disorders
Keywords: Cocaine
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to receive either progesterone or placebo during month 1, then crossover in month 2.

During each month, participants will be randomized to receive either an active or inactive dose of cocaine during a 4-day in-hospital testing visit for a total of 4 testing days with self-administered cocaine.
Primary purpose: TREATMENT

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 cocaine's 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.

Eligibility criteria: Inclusion Criteria:

* Smoked at least 1 gram of cocaine each week for the 6 months prior to study entry
* Agrees to use an adequate method of contraception for the duration of the study
* If female, current regular menses

Exclusion Criteria:

* Major psychiatric illnesses, including psychotic mood and anxiety disorders
* Current dependence on alcohol or drugs other that cocaine or nicotine
* History of major medical illnesses, including liver disease, abnormal vaginal bleeding, suspected or known breast cancer, thrombophlebitis, or other medical conditions
* Current use of oral contraceptives or other types of hormonal contraceptives
* Amenorrhea
* Currently on parole or probation
* Received treatment for chemical dependency within the 6 months prior to study entry
* Known allergy to progesterone or peanuts

Primary outcomes:
measure: Decision to Self-Administer Cocaine
timeFrame: 4 days
Secondary outcomes:
measure: Heart Rate
timeFrame: 4 days
measure: Systolic Blood Pressure
timeFrame: 4 days
measure: Diastolic Blood Pressure
timeFrame: 4 days
measure: Cocaine Craving
timeFrame: 4 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sheila M. Specker, MD
role: PRINCIPAL_INVESTIGATOR
References: