Responses to Marijuana-Related Cues Versus Neutral Cues in Adults Taking Tetrahydrocannabinol (THC) - 2

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leslie Lundahl, Wayne State University
ClinicalTrials.gov Identifier:
NCT00218504
First received: September 16, 2005
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

The majority of past research on marijuana treatment has targeted the alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. Treatment with tetrahydrocannabinol (THC), the main ingredient in marijuana responsible for its reinforcing effects, may decrease marijuana cravings. The purpose of this study is to evaluate the effect of THC pre-treatment on responses to marijuana-related cues versus non marijuana-related cues in individuals addicted to marijuana.


Condition Intervention Phase
Marijuana Abuse
Drug: Tetrahydrocannabinol
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cue Reactivity Model for Assessing Pharmacologic Intervention in Treatment of Cannabis Use Disorders (Study 2)

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Marijuana craving [ Time Frame: Measured throughout the cue exposure session ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2005
Study Completion Date: October 2009
Intervention Details:
    Drug: Tetrahydrocannabinol
    Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo.
Detailed Description:

Marijuana is the most commonly used illegal drug in the United States; more than 2 million Americans either abuse or are dependent on the drug. Therefore, there is a clear need for treatment options. Past research on marijuana treatments has focused on alleviating withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. Treatment with THC, a component of marijuana that causes the "high" sensation, may reduce marijuana cravings. This study will evaluate the subjective and physiological responses to marijuana-related cues versus non marijuana-related cues in marijuana users who have been pre-treated with THC.

Participants will attend three 6-hour sessions, each separated by at least 7 days. Prior to each testing session, participants will spend the night at the Psychiatric and Addiction Research Center at Detroit Receiving Hospital in order to ensure no alcohol or drug use during the 12 hours preceding the session. Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo. They will then undergo a cue exposure test during which they will be shown a nature video and will be asked to handle and smell various items; these will act as neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues. Heart rate and skin temperature will be monitored continuously throughout each session with the use of electrodes and a skin thermometer. Prior to and after the cue exposure sessions blood pressure will be measured and questionnaires will be administered to assess drug cravings as well as related mood states. Prior to leaving the clinical center, the participants' vital signs will be evaluated to ensure that any cue-related physiological changes have returned to normal. Following the end of the study session, participants will have the option of talking to a clinician experienced in dealing with drug cravings.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Marijuana dependent volunteers.

Criteria

Inclusion Criteria:

  • Meets DSM-IV diagnosis criteria for marijuana dependence
  • Able to read and write in English
  • Positive urine test for marijuana
  • If female, must be willing to use contraception throughout the study

Exclusion Criteria:

  • Meets DSM-IV diagnosis criteria for a psychiatric illness
  • History of a psychotic disorder
  • Seeking treatment for marijuana dependence
  • Neurologic disease, including structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, head trauma resulting in unconsciousness, or evidence of neurologic illness resulting from HIV/AIDS
  • Cardiovascular disease, including edema, chest pain or palpitations after exertion or drug use, myocardial infarction (heart attack), systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg, or diastolic blood pressure greater than 95 mm Hg
  • Pulmonary disease, including apnea, cor pulmonale, tuberculosis, dyspnea, orthopnea, or tachypnea
  • Systemic disease, including endocrinopathies, kidney or liver failure, hypothyroidism, adrenocortical insufficiency, or autoimmune disease involving the central nervous system
  • Currently dependent on any drug other than marijuana or nicotine
  • Cognitively impaired
  • Pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218504

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Leslie H. Lundahl Wayne State University
  More Information

No publications provided

Responsible Party: Leslie Lundahl, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT00218504     History of Changes
Other Study ID Numbers: NIDA-19236-2, R21DA019236, DPMCDA
Study First Received: September 16, 2005
Last Updated: June 1, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014