Progesterone for the Treatment of Cocaine Dependence - 1
Condition: Cocaine Abuse; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 200mg progesterone twice daily; placebo
Other intervention name(s): prometrium
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cocaine