Cognitive Enhancement as a Target for Cocaine Pharmacotherapy
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      Specific Aim #1: To determine if galantamine (8 or 16 mg/day) is more effective than placebo
      in reducing cocaine use as measured by cocaine urine results and self-report days of use.

      Specific Aim # 2: To determine if galantamine (8 or 16 mg/day) is more effective than placebo
      in improving attention, assessed with the Rapid Visual Information Processing (RVIP) and the
      Simple Reaction Time (SRT) tests Specific Aim # 3: To determine if improvement in attention
      during the first four weeks of treatment will mediate galantamine's efficacy in reducing
      cocaine use.
    

Detailed description: 
      This will be a double-blind, placebo-controlled, randomized clinical trial. One hundred and
      twenty cocaine-dependent men and women will be randomized to one of three treatment groups:
      placebo (n=40), 8 mg/day (n=40), and 16 mg/day (n=40) of extended release (ER) galantamine.
      An urn randomization will be used to balance the groups for gender, severity of cocaine use
      (measured by days of cocaine use), baseline cognitive functioning [determined via the Shipley
      Institute of Living Scale (SILS)], and smoking status. Gender and severity of cocaine use
      have been shown to predict treatment responses in cocaine users (76). Similarly, balancing
      the treatment groups for baseline cognitive functioning, assessed with the SILS scores, will
      minimize the influence of baseline differences on cognitive outcomes (77, 78). Smoking status
      is also an important baseline variable, given galantamine's actions on nicotinic receptors
      and its potential efficacy for smoking cessation (65). The initial dose of galantamine will
      be 8 mg/day as a single dose, as recommended for clinical use. For those assigned to 16
      mg/day, the dose of galantamine will be increased to 16 mg at the end of week 4. Treatment
      groups will remain on their full dosage through week 13. All participants will receive
      contingency management (CM) targeting treatment compliance. In three previous cocaine
      pharmacotherapy trials using bupropion, desipramine or levodopa, medication efficacy on
      cocaine use was evident only when medications were combined with CM, but not with standard
      care (79-81). These findings provide a strong rationale for using CM in our clinical trial.

      Recruitment is continuing. This protocol was amended as of May 2014 to come to one dispensing
      visit and up too, two clinic visits. The payment has changed from gift cards to cash. This
      change should help increase the number of completers.

      Currently there are 40 completers with 9 active and 6 in follow up phase. The follow up phase
      ended June 2016. Currently in analysis.
    

Intervention name(s): Galantamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8mg or 16mg; Placebo dose.
Other intervention name(s): Razadyne; Razadyne ER; Sugar Pill
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine use decreases, increases or stays the same