Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
キーワード
概要
説明
Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine users. The cognitive performance will be measured with the Stroop test and 3 Cambridge Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL), Delayed Pattern Recognition Memory (PRM),and Rapid Visual Information Processing (RVIP). Performance on these tests has been shown to be impaired in abstinent cocaine users, compared to healthy controls.
Galantamine, compared to placebo, will not be associated with any significant changes in mood. Monitoring of mood will be achieved with 3 mood scales: 1) Center for Epidemiologic Studies Depression (CES-D) scale, Positive and Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS).
Currently this study is completed, Patients are no longer being enrolled. There were 28 completers. This study has been published.
日付
最終確認済み: | 01/31/2012 |
最初に提出された: | 01/22/2008 |
提出された推定登録数: | 02/03/2008 |
最初の投稿: | 02/04/2008 |
最終更新が送信されました: | 06/23/2013 |
最終更新日: | 07/30/2013 |
最初に提出された結果の日付: | 02/07/2012 |
最初に提出されたQC結果の日付: | 06/23/2013 |
最初に投稿された結果の日付: | 07/30/2013 |
実際の研究開始日: | 05/31/2007 |
一次完了予定日: | 01/31/2009 |
研究完了予定日: | 01/31/2009 |
状態または病気
介入/治療
Drug: Galantamine 8 mg/day
Drug: Placebo
段階
アームグループ
腕 | 介入/治療 |
---|---|
Active Comparator: Galantamine 8 mg/day Galantamine 8 mg/day | Drug: Galantamine 8 mg/day Galantamine 8 mg/day |
Placebo Comparator: Placebo placebo | Drug: Placebo sugar pill |
適格基準
研究の対象となる年齢 | 21 Years に 21 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - Male and females, between the ages 21 and 50 - Fulfill criteria for past cocaine dependence - No cocaine use for the past 30 days - No other current dependence or abuse of other drugs or alcohol - No current medical problems and normal ECG - Not pregnant,nor breast feeding, - Using acceptable birth control methods. Exclusion Criteria: - Current major psychiatric illness including mood, psychotic or anxiety disorders - History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances - Use of other medications including,drugs that slow heart rate - Known allergy to galantamine |
結果
主な結果の測定
1. Performance on 3 Cognitive Tests From the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP, PAL and PRM. [Baseline, Day 5 and Day 10]
二次的な結果の測定
1. Performance on the Sustained Attention to Response Task (SART). [Baseline, Day 5 and Day 10]
2. Performance on the Modified Stroop Task (Cocaine-Stroop) [Baseline, Day 5 and Day 10]