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N/A Completed N=93 Randomized Double-blind Treatment

Cognitive Enhancement as a Target for Cocaine Pharmacotherapy

Source: ClinicalTrials.gov NCT01531153 ↗
Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Urine Toxicology — 16.1; 17; 14.9 average cocaine positive urine samples

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Urine Toxicology
16.1; 17; 14.9
SECONDARY
Heart Rate
78.85; 77.76; 75.01; 80.24; 79.74; 77.13
SECONDARY
Blood Pressure- Systolic
133.62; 127.75; 132.21; 132.04; 125.70; 136.68
SECONDARY
Blood Pressure- Diastolic
77.42; 78.75; 79.54; 79.13; 75.75; 80.88
SECONDARY
CANTAB RVIP Measure: RVP A
.86; .86; .85; .88; .84; .87
SECONDARY
CANTAB RVIP Measure: RVP B
.77; .91; .77; .77; .91; .77
SECONDARY
CANTAB RVIP Measure: RVP FALSE ALARM
.04; .01; .03; .03; .03; .02
SECONDARY
CANTAB SST- SSRT
215.3; 277.2; 244.1; 241.9; 267.9; 234.8
SECONDARY
CANTAB SST- Median Correct
706.3; 619.7; 680.0; 608.6; 669.7; 631.5
SECONDARY
CANTAB SST- SD Correct
276.5; 302.3; 363.4; 337.8; 410.6; 492.6
SECONDARY
Stroop- RT Correct Neutral
785.18; 805.24; 871.07; 821.37; 813.66; 845.66
SECONDARY
Stroop- RT Correct Drug
795.40; 806.57; 872.44; 825.09; 815.97; 846.59
SECONDARY
Stroop- Effect Drug Neutral Mean Correct
.22; 1.33; 1.37; 3.71; 2.31; 0.92
SECONDARY
Digit Span- LDSF
5.9; 5.7; 6.4; 6.5; 6.8; 7.4
SECONDARY
Digit Span- DSF
9.3; 9.9; 10.7; 10.5; 10.7; 11.2
SECONDARY
Digit Span- LDSB
4.2; 3.2; 4.0; 4.2; 4.3; 3.9
SECONDARY
Digit Span- DSB
8.3; 7.2; 7.6; 8.3; 8.5; 7.3

Eligibility Criteria

Inclusion Criteria

  • Male and females, between the ages of 18 and 60
  • Are using cocaine more than once per week in the previous 30 days, provide a cocaine-positive urine specimen at screening, and fulfill criteria for current cocaine dependence according to DSM-IV
  • For women of child-bearing age, have a negative pregnancy test at screening, agree to adequate contraception to prevent pregnancy, and agree to have monthly pregnancy tests
  • Are fluent in English and have a 6th grade or higher reading level; AND
  • Can commit to at least 13 weeks of treatment and are willing to be randomized to treatment

Exclusion Criteria

  • Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or have a depressive or anxiety disorder with current use of a prescribed psychotropic medication that cannot be discontinued
  • Current DSM-IV diagnosis of drug or alcohol dependence (other than cocaine, or tobacco)
  • Demonstrate significant medical conditions, including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal deficit and cardiac rhythm disturbances or any other medical conditions that the study physician deems contraindicated for galantamine treatment
  • Use of other medications including:
  • drugs that slow heart rate (e.g., beta-blockers), which may increase the risk of bradycardia and atrioventricular (AV) block and
  • non-steroidal anti-inflammatory drugs (NSAIDs); increased potential for developing ulcers/active or occult gastrointestinal bleeding
  • Have a screening liver function test (AST or ALT) greater than 3 times normal; OR
  • Known allergy or adverse reaction to galantamine
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01531153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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