Progesterone for the Treatment of Cocaine Dependence - 1

NCT00218257 | Completed Results DMC

• 3 other identifiers: 0205M23681R01DA014573DPMC
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Abuse; Cocaine-Related Disorders

Keywords

Cocaine

Outcome Measures

Primary Outcomes (1)

• Decision to Self-Administer Cocaine

  During 1 inpatient testing day, participants were given the opportunity to spend 5 earned tokens on either an active dose of cocaine or to keep the tokens for a $5 reward for each token. Decisions were solicited every 30 minutes. Outcome measure is reported as the percent of 5 decisions for which the participant chose to self-administer cocaine. 0% indicates that all 5 tokens were retained and traded for monetary reward. 100% indicates that the participant spent all 5 tokens on cocaine for self-administration. On another inpatient day, participants were offered the same 5 choices but with a inactive dose of cocaine (amount of cocaine insufficient for psychoactive effect) or a $5 monetary reward. 0% indicates that all 5 tokens were retained and traded for monetary reward. 100% indicates that the participant spent all 5 tokens on inactive doses of cocaine for self-administration. The order of days (active or inactive cocaine dosage) was random.

  4 days

Secondary Outcomes (4)

• Heart Rate

  4 days

• Systolic Blood Pressure

  4 days

• Diastolic Blood Pressure

  4 days

• Cocaine Craving

  4 days

Study Arms (2)

Progesterone

ACTIVE COMPARATOR

200mg progesterone twice daily

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

Placebo twice daily

Other: Placebo

Interventions

Progesterone DRUG

200mg progesterone twice daily

Also known as: prometrium

Progesterone

Placebo OTHER

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Dr. Sheila Specker
• Organization: University of Minnesota

speck001@umn.edu

612-273-9806

Study Officials

• Sheila M. Specker, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2002
• Primary Completion: April 1, 2008
• Study Completion: June 30, 2008
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (1)