Progesterone for the Treatment of Cocaine Dependence - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218257
First received: September 16, 2005
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Cocaine Abuse
Cocaine-Related Disorders
Drug: Progesterone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Interactions Between Progesterone and Cocaine in Women

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 1. The number of self-administered cocaine deliveries at each dose of cocaine (0.4 mg/kg or placebo) as a function of treatment with progesterone at 3 doses. 2. Subjective effects of cocaine as measured by cocaine effects questionnaire [ Time Frame: 1. Subjects could receive up to 5 doses of cocaine during each session. 2. The CEQ was given approximately every 5 minutes during each 3 hour session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • heart rate and blood pressure and plasma cocaine levels [ Time Frame: physiological monitoring every 2-5 minutes; cocaine levels baseline, +10 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: July 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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, they 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. They 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

Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218257

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Sheila M. Specker, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Sheila Specker, MD, University of Minnesota - Dept. of Psychiatry
ClinicalTrials.gov Identifier: NCT00218257     History of Changes
Other Study ID Numbers: NIDA-14573-1, R01DA014573, DPMC
Study First Received: September 16, 2005
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014