Progesterone for the Treatment of Cocaine Dependence - 1

NCT ID: NCT00218257

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2008-06-30

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.

Conditions

Cocaine Abuse; Cocaine-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Progesterone

200mg progesterone twice daily

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

200mg progesterone twice daily

Placebo

Placebo twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo

Interventions

Progesterone

200mg progesterone twice daily

Intervention Type: DRUG

Placebo

placebo

Intervention Type: OTHER

Other Intervention Names

prometrium

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila M. Specker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

R01DA014573

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

0205M23681

Identifier Type: -

Identifier Source: org_study_id