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- Klinische Studie NCT01863095
An Exercise App to Reduce Young Adults' MJ Use
29. Januar 2016 aktualisiert von: R. Lorraine Collins, Ph.D., State University of New York at Buffalo
Use of Exercise to Reduce Young Adult Marijuana Use: There is an App for That
Currently, marijuana (MJ) is the most popular illicit drug, but there are few effective interventions to help young adults (age 18 to 25 years) to reduce their MJ intake.
In this study, we will develop and initially test a smart phone app designed to promote exercise/physical activity as a positive alternative to MJ use.
The app will be tested in an efficacy study in which MJ users are randomly to either receive personalized feedback about MJ use + use the exercise app or personalized feedback only.
The results will contribute to knowledge about exercise/physical activity as a strategy for reducing young adults' MJ use and problems.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Currently, marijuana (MJ) is the most popular illicit drug, with prevalence studies indicating increasing use among young adults (Johnston et al., 2011).
Even so, there are few effective interventions to help MJ users reduce their intake to avoid negative consequences, including MJ dependence.
The investigators propose a Stage 1 efficacy study to develop and initially test an innovative intervention to reduce MJ use among young adults who regularly use MJ (> 3 episodes/week).
The intervention includes elements from the Marijuana Check-Up (MCU; Stephens et al., 2007), a MI-based brief intervention that has shown promise for reducing MJ use.
It also incorporates findings from our ongoing research, which suggest that exercise/physical activity (PA) has potential as a positive alternative to MJ use.
The investigators research also has shown that short (i.e., 10 minute) bouts of moderate or intense exercise reduce craving/urges to use MJ.
Exercise interventions have successfully reduced use of licit substances, such as tobacco (e.g., Marcus et al., 2005) and alcohol (e.g., Brown et al., 2009), but have not been adequately tested for MJ use.
The two aims of this R34 application are: 1) To develop an intervention that consists of four, 60-minute, in-person sessions composed of MCU content (e.g., personalized feedback, MI) as well as a smart phone application (app) that promotes exercise/physical activity (EA) as an alternative to MJ use.
The EA, which will be designed to specifically appeal to young adults, will provide a readily-accessible, flexible, and convenient platform for personalized information and reminders that promote exercise/PA as a positive alternative to MJ use in ongoing daily life.
2) To conduct a pilot/efficacy study of the 4-week MCU+EA intervention vs. a MCU-only control condition.
The investigators will use urn randomization to assign emerging/young-adult MJ users (N = 40) to the two conditions.
During the 1-week baseline, 4-week intervention phase, and 1-, 3-, and 6-month follow-ups, all participants will use the smart phone app to provide real-time data on MJ-related variables and wear accelerometers to provide PA data.
Multilevel modeling will be used to test our hypothesis that the MCU+EA intervention, compared to MCU-only control, will produce greater decreases in quantity and frequency of MJ use (and related MJ problems) at post-intervention and at each follow-up.
Multilevel modeling also will be used to explore the real-time data to examine the role of variables such as urge/craving for MJ, social factors, and dosage of PA in the reduction of the quantity and frequency of MJ use.
This Stage 1 study is unique and innovative in its development and use of a smart phone app to promote and evaluate exercise/PA as a positive alternative to MJ use in daily life.
It includes cutting-edge technology (e.g., accelerometers, smart phone app) for real-time assessments.
This research will make significant contributions to the limited knowledge of exercise/PA as a strategy for reducing MJ use and related problems among emerging and young adults.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
36
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New York
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Buffalo, New York, Vereinigte Staaten, 14214
- Center for Health Research
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 25 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Regular Marijuana user interested in cutting down on marijuana use
- Body Mass Index < 30
Exclusion Criteria:
- Pregnant or planning to become pregnant
- No legal problems
- No substance abuse diagnosis
- No history of substance abuse treatment
- Medical contraindications to engaging in exercise
- Psychological distress or psychiatric treatment
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Lifestyle counseling
MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles.
They will receive personalized feedback on their MJ use and will be provided a smart phone app on which they report their MJ use episodes, which also is designed to promote the use of exercise/physical activity as an alternative to MJ use.
Level of Physical activity will be measured using accelerometers.
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Aktiver Komparator: Personalized Feedback only
MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles.
They will only receive personalized feedback on their MJ use.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Physical Activity
Zeitfenster: Change in exercise at 1 month, 3 months, and 6 months after interventionts
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Counts based on data collected by accelerometers.
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Change in exercise at 1 month, 3 months, and 6 months after interventionts
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Substance Use
Zeitfenster: Change in marijuana use at 1 month, 3 months, and 6 months after intervention
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Change in marijuana use at 1 month, 3 months, and 6 months after intervention
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: R Lorraine Collins, Ph.D., State University of New York at Buffalo
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2014
Primärer Abschluss (Tatsächlich)
1. Mai 2015
Studienabschluss (Tatsächlich)
1. Juni 2015
Studienanmeldedaten
Zuerst eingereicht
21. Mai 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Mai 2013
Zuerst gepostet (Schätzen)
27. Mai 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
1. Februar 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Januar 2016
Zuletzt verifiziert
1. Januar 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R34DA035358 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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