Addiction Clinical Trial
Official title:
Cognitive Enhancement as a Target for Cocaine Pharmacotherapy
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03576768 -
QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt
|
N/A | |
Completed |
NCT04110626 -
Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine
|
||
Completed |
NCT03007940 -
Using NIATx Strategies to Implement Integrated Services in Routine Care
|
N/A | |
Not yet recruiting |
NCT04030858 -
The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
|
N/A | |
Completed |
NCT03347643 -
The Effectiveness of tDCS on Internet Game Addiction
|
Phase 2 | |
Active, not recruiting |
NCT02836080 -
Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
|
N/A | |
Completed |
NCT03221985 -
ESM Pilot: Mobile Phones and Psychology
|
N/A | |
Completed |
NCT02556060 -
Lamotrigine for Ketamine Dependence Trial
|
Phase 2/Phase 3 | |
Completed |
NCT02812810 -
Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence
|
N/A | |
Recruiting |
NCT05976646 -
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
|
Phase 1/Phase 2 | |
Completed |
NCT04409106 -
The Turkish Version of the Parental Smartphone Use Management Scale (PSUMS)
|
||
Not yet recruiting |
NCT06459609 -
Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment
|
N/A | |
Recruiting |
NCT05595759 -
Violence Against Women in Patients With Alcohol Substance Addiction Training
|
N/A | |
Completed |
NCT04099173 -
A Brief Mindfulness-Based Intervention for Suicidal Ideation
|
N/A | |
Recruiting |
NCT04959643 -
Systematic Screening for Viral Hepatitis B and C at the PASS Consultation of the Montpellier University Hospital
|
||
Completed |
NCT04133688 -
Mobile App in Addiction
|
N/A | |
Recruiting |
NCT04063267 -
Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
|
Phase 2 | |
Completed |
NCT05114577 -
Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
|
N/A | |
Terminated |
NCT02671240 -
Prognosis of Behavioral Addiction in Parkinson's Disease
|
||
Not yet recruiting |
NCT03813095 -
Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction
|
Phase 2 |